FDA 510(k) Applications for Medical Device:
Nail, Fixation, Bone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K021782 | AAP IMPLANTATE AG |
LORENZWEG 5 | BERLIN | 12099 | |
| K192003 | Auxein Medical Private Limited |
Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli | Sonepat | 131028 | |
| K011504 | BAUMER S.A. |
AV. PREF. ANTONIO TAVARES | MOGI MIRIM, SAO PAULO | 13803-330 | |
| K002325 | BIOLOGICALLY ORIENTED PROSTHESES |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K193533 | Biomet Inc. |
56 East Bell Drive, PO Box 587 | Warsaw | IN | 46581 |
| K000764 | BIOMET, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K141737 | CONVENTUS ORTHOPAEDICS, INC. |
10200 73RD AVE. N, STE 122 | MAPLE GROVE | MN | 55369 |
| K003212 | DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
COLUMBIA SQUARE | WASHINGTON | DC | 20004-1109 |
| K003215 | DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
COLUMBIA SQUARE | WASHINGTON | DC | 20004-1109 |
| K993004 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K080706 | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
3150 E. 200TH ST. | PRIOR LAKE | MN | 55372 |
| K991877 | INNERVISION, INC. |
6258 SHADY GROVE RD. E. | MEMPHIS | TN | 38120 |
| K991037 | MODULAR CUTTING SYSTEMS, INC. |
650 CLINTON AVE. | BRIDGEPORT | CT | 06605 |
| K032634 | NOVIACE CORPORATION |
809 CARTER LANE | PARAMUS | NJ | 07652 |
| K014189 | ORTHOPEDIC DESIGNS, INC. |
6965 1ST AVE., NORTH | ST. PETERSBURG | FL | 33710-8303 |
| K230761 | Smith & Nephew Inc. |
1450 Brooks Rd E | Memphis | TN | 38116 |
| K123948 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K983942 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K050938 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K061783 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K981529 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K040212 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K061019 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K051557 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K033071 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K972516 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K062872 | SYNTHES (USA) |
1301 GOSHEN PKWY | WEST CHESTER | PA | 19380 |
| K072095 | SYNTHES (USA) |
1301 GOSHEN PKWY. | WEST CHESTER | PA | 19380 |
| K040762 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K002729 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K992348 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K111667 | SYNTHES (USA) |
1301 GOSHEN PKWY. | WEST CHESTER | PA | 19380 |
| K962047 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K201336 | Synthes (USA) Products, LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
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