The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Super Revo Suture Anchor.
| Device ID | K003984 |
| 510k Number | K003984 |
| Device Name: | SUPER REVO SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Seneff |
| Correspondent | Laura D Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | MAI |
| Subsequent Product Code | GAS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854019815 | K003984 | 000 |
| 20845854012311 | K003984 | 000 |