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 |
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 |
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 |
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 |
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 |
|
|