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 |