FDA 510(k) Applications for Medical Device:
Cerclage, Fixation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K180582 | A & E Medical Corporation |
5206 Asbury Road | Farmingdale | NJ | 07727 |
| K193479 | A&E Medical Corporation |
5206 Asbury Road, PO Box 758 | Farmingdale | NJ | 07727 |
| K181607 | A&E Medical Corporation |
5206 Asbury Road, PO Box 758 | Farmingdale | NJ | 07727 |
| K173579 | A&E Medical Corporation |
5206 Asbury Road, PO Box 758 | Farmingdale | NJ | 07727 |
| K060009 | ABBOTT SPINE, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K081622 | ABBOTT SPINE, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K960651 | ACU-MED, INC. |
10950 SW 5TH, SUITE 170 | BEAVETON | OR | 97005 |
| K063017 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K243344 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108 |
| K230976 | Arthrex, Inc |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K170206 | ARTHREX, INC. |
1370 CREEKSIDE BOULEVARD | NAPLES | FL | 34108-1945 |
| K071271 | BIOMET MANUFACTURING, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0578 |
| K110039 | BIOMET SPORTS MEDICINE |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K982545 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K133354 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K173910 | Cable Fix Medical LLC |
1050 Getwell Road S | Hernando | MS | 38632 |
| K232986 | CircumFix Solutions, Inc. |
475 East South St. | Collierville | TN | 38017 |
| K101484 | DALLEN MEDICAL |
1046 CALLE RECODO | SAN CLEMENTE | CA | 92673 |
| K130431 | DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G | San Clemente | CA | 92673 |
| K143716 | DSM BIOMEDICAL |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K110541 | FIGURE 8 SURGICAL, INCORPORATED |
155-A MOFFETT PARK DRIVE, | SUNNYVALE | CA | 94089 |
| K151888 | FRONTIER MEDICAL DEVICES, INC. |
512 FOURTH STREET | GWINN | MI | 49841 |
| K153242 | FRONTIER MEDICAL DEVICES, INC. |
512 FOURTH STREET | GWINN | MI | 49841 |
| K151346 | FRONTIER MEDICAL DEVICES, INC. |
512 FOURTH STREET | GWINN | MI | 49841 |
| K231333 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K971741 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K961283 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K961569 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K962162 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K984432 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K202016 | Howmedica Osteonics Corp., dba Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K121541 | IMPLANET S.A. |
1835 MARKET ST. | PHILADELPHIA | PA | 19103 |
| K103797 | K2M, INC. |
751 MILLER DR.,SE | LEESBURG | VA | 20175 |
| K102834 | KINAMED INCORPORATED |
820 FLYNN ROAD | CAMARILLO | CA | 93012 |
| K030256 | KINAMED, INC. |
820 FLYNN RD. | CAMARILLO | CA | 93012 |
| K181749 | Kinamed, Incorporated |
820 Flynn Road | Camarillo | CA | 93010 |
| K151983 | KLS MARTIN L.P. |
11201 SAINT JOHNS INDUSTRIAL | JACKSONVILLE | FL | 32246 |
| K232733 | Medacta International S.A. |
Strada Regina | Castel San Pietro | 6874 | |
| K112736 | MEDICREA INTERNATIONAL |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K983976 | METAGEN, L.L.C. |
428 TECHNOLOGY DR. EAST | MENOMONIE | WI | 54751 |
| K211613 | Neos Surgery SL |
Parc Technologic del Valles | Barcelona | 08290 | |
| K221795 | Neos Surgery SL |
Parc Technologic del Valles | Barcelona | 08290 | |
| K001254 | ORTHOMATRIX, INC. |
711 CHANEY COVE | COLLIERVILLE | TN | 38017 |
| K023564 | OSSEUS, LLC |
34 WOODLANE RD. | LAWRENCEVILLE | NJ | 08648 |
| K040199 | OSSEUS, LLC |
3131 PRINCETON PIKE | LAWRENCEVILLE | NJ | 08648 |
| K962132 | OSTEONICS CORP. |
2 PEARL COURT | ALLENDALE | NJ | 07401-1677 |
| K972327 | PACIFIC MATERIALS AND INTERFACES |
4329 GRAYDON RD. | SAN DIEGO | CA | 92130 |
| K000694 | PECTOFIX, INC. |
481 MEMORIAL PKWY. | METUCHEN | NJ | 08840 |
| K003951 | PECTOFIX, INC. |
2509 PARK AVE. | SOUTH PLAINFIELD | NJ | 07080 |
| K980690 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K974016 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K993286 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K961267 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855 |
| K992616 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K002110 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K001709 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855 |
| K133785 | PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855 |
| K201497 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
375 River Park Circle | Marquette | MI | 49855 |
| K150581 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
375 River Park Circle | Marquette | MI | 49855 |
| K193468 | Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) |
375 River Park Circle | Marquette | MI | 49855 |
| K161876 | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
375 River Park Circle | Marquette | MI | 49855 |
| K973098 | PLUS ORTHOPEDICS |
835 CORTEZ LN. | FOREST CITY | CA | 94404 |
| K220765 | Riverpoint Medical, LLC |
815 NE 25th Ave | Portland | OR | 97232 |
| K090686 | SIC BREVETTI S.R.L. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K233949 | Smith & Nephew, Inc. |
1450 Brooks Road | Memphis | TN | 38116 |
| K043252 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K031162 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K974020 | SPINAL CONCEPTS, INC. |
820O CAMERON RD., SUITE B-160 | AUSTIN | TX | 78754 |
| K120177 | SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100 | CARLSBAD | CA | 92008 |
| K081205 | SYNTHES (USA) |
1301 GOSHEN PKWY | WEST CHESTER | PA | 19380 |
| K033816 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K050041 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K031508 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K992891 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K010943 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K110789 | SYNTHES (USA) |
1301 GOSHEN PARKWYA | WEST CHESTER | PA | 19380 |
| K953777 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K172975 | Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K970084 | TURNKEY INTERGRATION USA, INC. |
962 SOUTH TAMIAMI TRAIL, | SARASOTA | FL | 34326 |
| K993903 | WHITESIDE BIOMECHANICS, INC. |
12634 OLIVE BLVD. | ST. LOUIS | MO | 63141 |
| K091190 | ZIMMER SPINE, INC |
5301 RIATA PARK COURT | AUSTIN | TX | 78727 |
| K151848 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46580 |
| K150889 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
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