The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bio-anchor, Pre-loaded Bioabsorbable Suture Anchor.
| Device ID | K983186 |
| 510k Number | K983186 |
| Device Name: | BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | MAI |
| Subsequent Product Code | GAT |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-11 |
| Decision Date | 1998-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014322 | K983186 | 000 |