The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bio-anchor.
| Device ID | K963369 | 
| 510k Number | K963369 | 
| 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 (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1996-08-27 | 
| Decision Date | 1997-05-22 | 
| Summary: | summary | 
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  |