FDA 510(k) Applications for Medical Device:
Rongeur, Manual
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K200387 | Ace Medical |
2230 Park Ave. #202 | Cincinnati | OH | 45206 |
| K223596 | Aesculap Inc. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K080494 | BAXANO, INC. |
5582 CHALON ROAD | YORBA LINDA | CA | 92886 |
| K113073 | BAXANO, INC. |
655 RIVER OAKS PKWY | SAN JOSE | CA | 95134 |
| K063231 | BAXANO, INC. |
5582 CHALON ROAD | YORBA LINDA | CA | 92886 |
| K100958 | BAXANO, INC. |
655 RIVER OAKS PKWY | SAN JOSE | CA | 95134 |
| K113533 | BAXANO, INC. |
655 RIVER OAKS PKWY | SAN JOSE | CA | 95134 |
| K062711 | BAXANO, INC. |
5582 CHALON ROAD | YORBA LINDA | CA | 92886 |
| K023868 | DANNORITZER MEDICAL INSTRUMENTS |
271 WALDROUP RD. | HOT SPRINGS | NC | 28783 |
| K153243 | Fehling Instruments GmbH & Co. KG |
Hanauer Landstr. 7A | Karlstein | D-63791 | |
| K081651 | INSTRUMED INTERNATIONAL, INC. |
626 COOPER COURT | SCHAUMBURG | IL | 60173 |
| K150428 | INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K092227 | INTEGRA LIFESCIENCES CORP. |
589 DAVIES DR. | YORK | PA | 17402 |
| K150468 | K2 Medical GmbH & Co. KG |
Unter Buchsteig 5 | Tuttlingen | ||
| K210741 | KLS-MARTIN L.P. |
11201 Saint Johns Industrial Parkway South | Jacksonville | FL | 32246 |
| K230256 | Morpheus AG |
Bahnhofstra▀e 18 | Spaichingen | 78549 | |
| K200768 | Morpheus AG |
Bahnhofstra▀e 20 | Spaichingen | 78549 | |
| K221818 | Morpheus AG |
Bahnhofstra▀e 18 | Spaichingen | 78549 | |
| K131851 | OSTEOMED |
3885 ARAPAHO ROAD | ADDISON | TX | 75001 |
| K180949 | RJR Surgical, Inc. |
2530 Superior Avenue | Cleveland | OH | 44114 |
| K130541 | SYMMETRY SURGICAL |
1927 N. ARTHUR DR. | COLUMBIA CITY | IN | 46725 |
| K161744 | Symmetry Surgical Inc. |
3034 Owen Drive | Antioch | TN | 37013 |
| K152734 | VITALITEC MEDIZINTECHNIK GMBH |
STEIGAECKER 20 | BALGHEIM (BADEN-WURTTEM BERG) | 78582 | |
| K200383 | Wiggins Medical |
2230 Park Avenue #202 | Cincinnati | OH | 45206 |
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