FDA 510(k) Applications for Medical Device:
Orthosis, Cervical Pedicle Screw Spinal Fixation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K151938 | AESCULAP IMPLANT SYSTEMS, LLC |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K213871 | Aesculap Implant Systems, LLC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K191185 | Alphatec Spine |
5818 El Camino Real | Carlsbad | CA | 92008 |
| K200936 | Alphatec Spine, Inc. |
5818 El Camino Real | Carlsbad | CA | 92008 |
| K203125 | Alphatec Spine, Inc. |
5818 El Camino Real | Carlsbad | CA | 92008 |
| K210887 | Altus Partners, LLC |
1340 Enterprise Drive | West Chester | PA | 19380 |
| K171250 | Astura Medical |
3186 Lionshead Ave, Suite 100 | Carlsbad | CA | 92010 |
| K151224 | BIOMET SPINE |
310 INTERLOCKEN PARKWAY, SUITE 120 | BROOMFIELD | CO | 80021 |
| K152211 | CENTINEL SPINE, INC. |
900 AIRPORT ROAD, SUITE 3B | WEST CHESTER | PA | 19380 |
| K200863 | CoreLink, LLC |
2072 Fenton Logistics Blvd. | St. Louis | MO | 63206 |
| K151885 | DEPUY SYNTHES, Inc. |
325 Paramount Drive | Raynham | MA | 02767 |
| K160697 | Exactech, Inc. |
2320 NW 66th Court | Gainesville | FL | 32653 |
| K171834 | G Surgical LLC |
9433 Bee Cave Road Building 3, Suite 101-A | Austin | TX | 78733 |
| K150552 | GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K211957 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K161591 | GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K192354 | Innovasis, Inc. |
614 East 3900 South | Salt Lake City | UT | 84107 |
| K182182 | K2M |
600 Hope Parkway SE | Leesburg | VA | 20175 |
| K181603 | K2M Inc. |
600 Hope Pkwy. SE | Leesburg | VA | 20175 |
| K171444 | K2M, Inc. |
600 Hope Parkway SE | Leesburg | VA | 20175 |
| K193129 | K2M, Inc. |
600 Hope Parkway SE | Leesburg | VA | 20175 |
| K153370 | K2M, Incorporated |
751 Miller Drive SE | Leesburg | VA | 20175 |
| K231840 | L & K Biomed Co., Ltd. |
#101, 201, 202 16-25, Dongbaekjungang-ro 16 | Yongin-si | 17015 | |
| K200793 | L&K BIOMED Co., Ltd. |
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, | Giheung-gu, Yongin-si | 17015 | |
| K153439 | L&K BIOMED CO., LTD. |
#201, 202 16-25, DONGBAEKJUNGANG-RO | Giheung-gu, Yongin-si | 446-916 | |
| K162136 | L&K BIOMED CO.,LTD. |
#201, 202 16-25, DONGBAEKJUNGANG-RO 16 BEON-GIL | GIHEUNG-GU, YONGIN-SI | 446-916 | |
| K200896 | Life Spine Inc. |
13951 S Quality Drive | Huntley | IL | 60142 |
| K162266 | LIFE SPINE INC. |
13951 S QUALITY DRIVE | HUNTLEY | IL | 60142 |
| K170804 | Life Spine Inc. |
13951 S Quality Drive | Huntley | IL | 60142 |
| K173047 | Life Spine, Inc. |
13951 S. Quality Drive | Huntley | IL | 60142 |
| K220570 | Medacta International S.A. |
Strada Regina | Castel San Pietro | CH-6874 | |
| K182837 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K171369 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K190631 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K200130 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K203149 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K220810 | Medicrea International |
5389 Route de Strasbourg - Vancia | Rillieux-La-Pape | 69140 | |
| K153169 | MEDICREA INTERNATIONAL |
14 Porte du Grand Lyon | NEYRON | 01700 | |
| K161149 | MEDICREA INTERNATIONAL S.A |
14 PORTE DU GRAND LYON | NEYRON | 01700 | |
| K150918 | MEDICREA INTERNATIONAL S.A. |
14 PORTE DU GRAND LYON | NEYRON | 01700 | |
| K160756 | MEDICREA INTERNATIONAL S.A. |
14 Porte du Grand Lyon | NEYRON | 01700 | |
| K190895 | Medos International Sarl |
Chemin-Blanc 38 | Le Locle | 2400 | |
| K203319 | Medos International Sarl |
Chemin Blanc 38 | LeLocle | 2400 | |
| K181949 | Medos International SARL |
Chemin-Blanc 38 | Le Locle | 2400 | |
| K192646 | Medos International SARL |
Chemin-Blanc 38 | Le Locle | 2400 | |
| K192014 | Medos International SARL |
Chemin-Blanc 38 | Le Locle | 2400 | |
| K210449 | Medtronic |
1800 Pyramid Place | Memphis | TN | 38132 |
| K143471 | Medtronic Sofamor Danek USA, Inc |
1800 Pyramid Place | Memphis | TN | 38132 |
| K152338 | MEDTRONIC SOFAMOR DANEK USA, INC |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K180851 | Medtronic Sofamor Danek USA, Inc |
1800 Pyramid Place | Memphis | TN | 38132 |
| K223764 | Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K163375 | Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K161637 | Medyssey USA, Inc. |
1550 E. Higgins Road, Suite 123 | Elk Grove Village | IL | 60007 |
| K182508 | Nexxt Spine LLC |
14425 Bergen Blvd, Suite B | Noblesville | IN | 46060 |
| K191553 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K221388 | NuVasive, Incorporated |
7475 Lusk Blvd. | San Diego | CA | 92121 |
| K213654 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K150474 | NuVasive, Incorporated |
7475 Lusk Blvd. | San Diego | CA | 92121 |
| K180198 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K153336 | NUVASIVE, INCORPORATED |
7475 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K211710 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K180025 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K201481 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K170647 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K172194 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K190751 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K150822 | ORTHOFIX, INC. |
3451 PLANO PARKWAY | LEWISVILLE | TX | 75056 |
| K222107 | Osseus Fusion Systems |
1931 Greenville Ave | Dallas | TX | 75206 |
| K161498 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
375 River Park Circle | Marquette | MI | 49855 |
| K172139 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
375 River Park Circle | Marquette | MI | 49855 |
| K162300 | PRECISION SPINE, INC. |
2050 EXECUTIVE DRIVE | PEARL | MS | 39208 |
| K172495 | Precision Spine, Inc. |
2050 Executive Drive | Pearl | MS | 39208 |
| K172279 | Providence Medical Technology, Inc. |
1331 N. California Blvd. Suite 320 | Walnut Creek | CA | 94596 |
| K231654 | SeaSpine Inc. |
5770 Armada Dr. | Carlsbad | CA | 92008 |
| K193615 | SeaSpine Orthopedics Corporation |
5770 Armada Drive | Carlsbad | CA | 92008 |
| K220658 | SIGNUS Medizintechnik GmbH |
Industriestra▀e 2 | Alzenau | 63755 | |
| K192013 | Silony Medical GmbH |
Leinfelder StraBe 60 | Leinfelden-Echterdingen | 70771 | |
| K151705 | SPINAL ELEMENTS, INC. |
3115 MELROSE DRIVE, STE 200 | CARLSBAD | CA | 92010 |
| K221307 | Spinal Simplicity LLC |
6363 College Boulevard Suite 320 | Overland Park | KS | 66211 |
| K172594 | Spine Wave, Inc. |
3 Enterprise Drive | Shelton | CT | 06484 |
| K181440 | Spine Wave, Inc. |
3 Enterprise Drive, Suite 210 | Shelton | CT | 06484 |
| K162639 | Spine Wave, Inc. |
3 Enterprise Drive, Suite 210 | Shelton | CT | 06484 |
| K153386 | SPINEART |
INTERNATIONAL CENTER COINTRIN | Geneva | 1215 | |
| K190071 | SPINEART |
3 Chemin du pre Fleuri | Plan Les Ouates | 1228 | |
| K200571 | SPINEART |
3 Chemin du Pre Fleuri | PLAN LES OUATES | 1228 | |
| K181350 | SpineCraft LLC |
777 Oakmont Lane | Westmont | IL | 60559 |
| K150539 | Stryker Corporation |
2 PEARL CT. | ALLENDALE | NJ | 07401-1677 |
| K151755 | Stryker Corporation |
2 Pearl Court | Allendale | NJ | 07401 |
| K142838 | SYNTHES USA PRODUCTS, LLC |
325 PARAMOUNT DRIVE | RAYNHAM | MA | 02767 |
| K183383 | U & I Corporation |
20, Sandan-ro 76beon-gil(Rd) | Uijeongbu-si | 11781 | |
| K150570 | U&I Corporation |
20, Sandan-ro 76beon-gil (Rd) | Uijeongbu-si | 480859 | |
| K150650 | ULRICH GMBH & CO. KG |
BUCHBRUNNENWEG 12 | ULM | 89081 | |
| K161032 | ULRICH GMBH & CO. KG |
BUCHBRUNNENWEG 12 | ULM | 89081 | |
| K230614 | ulrich medical USA |
18221 Edison Avenue | Chesterfield | MO | 63005 |
| K213394 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K223852 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K232167 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K160428 | X-spine Systems, Inc. |
452 Alexandersville Rd. | Miamisburg | OH | 45342 |
| K161478 | Xenco Medical, LLC |
9930 Mesa Rim Road | San Diego | CA | 92121 |
| K211993 | Zavation Medical Products LLC |
220 Lakeland Parkway | Flowood | MS | 39232 |
| K162575 | ZAVATION, LLC |
220 LAKELAND PARKWAY | FLOWOOD | MS | 39232 |
| K151031 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439 |
| K153631 | Zimmer Spine, Inc |
7375 Bush Lake Road | Minneapolis | MN | 55439 |
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