FDA 510(k) Applications for Medical Device:
Cover, Burr Hole
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040080 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K091692 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K130309 | BIOMET MICROFIXATION |
3416 ROXEE RUN COVE | BARTLETT | TN | 38133 |
| K001096 | IMAGE-GUIDED NEUROLOGICS, INC. |
2290 EAU GALLIE BLVD. | MELBOURNE | FL | 32935 |
| K002334 | MACROPORE BIOSURGERY, INC. |
6740 TOP GUN ST. | SAN DIEGO | CA | 92121 |
| K010361 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K160739 | Neos Surgery S.L. |
Parc Tecnologic del Valles, C/Ceramistes, 2 | Cerdanyola del Valles | 08290 | |
| K101235 | NEOS SURGERY S.L. |
901 KING STREET | ALEXANDRIA | VA | 22314 |
| K132044 | NEOS SURGERY S.L. |
901 KING STREET | ALEXANDRIA | VA | 22314 |
| K141368 | NEUROPACE INC |
455 N. BERNARDO AVE | MOUNTAIN VIEW | CA | 94043 |
| K123163 | NEUROPACE INC |
455 N. BERNARDO AVE | MOUNTAIN VIEW | CA | 94043 |
| K192162 | NeuroVention LLC |
645 S. Beach St. | Daytona Beach | FL | 32114 |
| K192310 | Ossaware Biotech Co., Ltd. |
No. 51, Xinggong Rd. | Shenkang Hsiang | 50971 | |
| K140309 | OSSDSIGN AB |
808 WILLIAMSON ST. SUITE 402 | MADISON | WI | 53703 |
| K181539 | OssDsign AB |
Virdings Alle 2 | Uppsala | SE 754 50 | |
| K071138 | PROSURG, INC. |
2195 TRADE ZONE BLVD. | SAN JOSE | CA | 95131 |
| K181382 | St Jude Medical |
6901 Preston Road | Plano | TX | 75024 |
| K152342 | ST. JUDE MEDICAL |
6901 PRESTON ROAD | PLANO | TX | 75024 |
| K042986 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K021408 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K041611 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K031654 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K123633 | TISSUE REGENERATION SYSTEMS, INC. |
5400 CARILLON POINT | KIRKLAND | WA | 98033 |
| K960656 | W.L. GORE & ASSOCIATES,INC |
3750 WEST KILTIE LN. | FLAGSTAFF | AZ | 86001 |
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