The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bio-anchor.
| Device ID | K955486 |
| 510k Number | K955486 |
| Device Name: | BIO-ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman, Ph.d. |
| Correspondent | Carol A Weideman, Ph.d. LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-02-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIO-ANCHOR 75024527 2078062 Live/Registered |
CONMED CORPORATION 1995-11-27 |
![]() BIO-ANCHOR 74261469 not registered Dead/Abandoned |
Linvatec Corporation 1992-04-01 |