FDA 510(k) Applications for Medical Device:
Drills, Burrs, Trephines & Accessories (Simple, Powered)
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K170442 |
Ad-Tech Medical Instrument Corporation |
1901 William Street
| Racine |
WI |
53404 |
| K130755 |
ADEOR MEDICAL AG |
KIRCHPLATZ 1
| PULLACH |
|
82049 |
| K191479 |
adeor Medical AG |
Biberger Str. 93
| Unterhaching |
|
82008 |
| K203739 |
Aesculap Inc. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
| K022942 |
AESCULAP, INC. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
| K172709 |
Aesculap, Inc. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
| K182527 |
Aesculap, Inc. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
| K183203 |
Aesculap, Inc. |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
| K213072 |
Biomet Micofixation |
1520 Tradeport Drive
| Jacksonville |
FL |
32218 |
| K223199 |
Biomet Microfixation |
1520 Tradeport Drive
| Jacksonville |
FL |
32218 |
| K213208 |
Biomet Microfixation |
1520 Tradeport Drive
| Jacksonville |
FL |
32218 |
| K161704 |
BIOTEX, INC. |
114 HOLMES RD
| HOUSTON |
TX |
77045 |
| K030172 |
BRASSELER USA I, L.P. |
4837 MCGRATH ST., SUITE J
| VENTURA |
CA |
93003 |
| K153519 |
CAREVATURE MEDICAL LTD |
42 Tvuot Haarets St.
| Tel Aviv |
|
6954648 |
| K230619 |
Hubly Inc. |
750 Warrenville Rd
| Lisle |
IL |
60532 |
| K984035 |
KOMET MEDICAL |
1679 KELLOGG SPRINGS DR.
| ATLANTA |
GA |
30338 |
| K072315 |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
4620 NORTH BEACH ST.
| FORT WORTH |
TX |
76137 |
| K213454 |
Medtronic Powered Surgical Solutions |
4620 North Beach Street
| Fort Worth |
TX |
76137 |
| K123270 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE
| MEMPHIS |
TN |
38132 |
| K182436 |
Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place
| Memphis |
TN |
38132 |
| K121264 |
MEDTRONIC SURGICAL TECHNOLOGIES |
4620 NORTH BEACH STREET
| FORT WORTH |
TX |
76137 |
| K081475 |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH
| JACKSONVILLE |
FL |
32216 |
| K111520 |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH
| JACKSONVILLE |
FL |
32216 |
| K014060 |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
1641 EDLICH DR.
| CHARLOTTESVILLE |
VA |
22911 |
| K132436 |
MRI INTERVENTIONS, INC. |
5 MUSICK
| IRVINE |
CA |
92618 |
| K202120 |
Nakanishi Inc. |
700 Shimohinata
| Kanuma |
|
322-8666 |
| K162542 |
OSTEOMED |
3885 ARAPAHO ROAD
| ADDISON |
TX |
75001 |
| K190172 |
Stryker |
4100 E. Milham Ave
| Kalamazoo |
MI |
49001 |
| K143320 |
STRYKER CORP. |
4100 E. MILHAM AVE.
| KALAMAZOO |
MI |
49001 |
| K143399 |
STRYKER CORP. |
4100 E. MILHAM AVE.
| KALAMAZOO |
MI |
49002 |
| K210377 |
Stryker Corporation |
1941 Stryker Way
| Portage |
MI |
49002 |
| K191049 |
Stryker Corporation |
4100 E Milham Ave
| Kalamazoo |
MI |
49001 |
| K143540 |
STRYKER CORPORATION |
4100 E. MILHAM AVE.
| KALAMAZOO |
MI |
49001 |
| K070876 |
STRYKER CRANIOMAXILLOFACIAL |
750 TRADE CENTRE WAY
| KALAMAZOO |
MI |
49002 |
| K250374 |
Stryker Instruments |
1941 Stryker Way
| Portage |
MI |
49002 |
| K032303 |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE.
| KALAMAZOO |
MI |
49001 |
| K232684 |
Surgify Medical OY |
Otakaari 5
| Espoo |
|
02150 |
| K250380 |
Surgify Medical Oy |
Otakaari 5
| Espoo |
|
02150 |
| K251433 |
Surgify Medical Oy |
Otakaari 5
| Espoo |
|
02150 |
| K040076 |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR.
| PALM BEACH GARDENS |
FL |
33410 |
| K002903 |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR.
| PALM BEACH GARDENS |
FL |
33410 |
| K050628 |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR.
| PALM BEACH GARDENS |
FL |
33410 |
| K113476 |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR.
| Palm Bch Gdns |
FL |
33410 |
| K183545 |
The Anspach Effort, Inc. |
4500 Riverside Drive
| Palm Beach Gardens |
FL |
33410 |
| K042783 |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR.
| PALM BEACH GARDENS |
FL |
33410 |
| K080802 |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR.
| PALM BEACH GARDENS |
FL |
33410 |
| K062842 |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR.
| JACKSONVILLE |
FL |
32218 |
|
|