The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Bio Mini-revo Suture Anchor.
| Device ID | K072291 |
| 510k Number | K072291 |
| Device Name: | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Jon Ward |
| Correspondent | Jon Ward CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2008-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854030926 | K072291 | 000 |
| 20845854014315 | K072291 | 000 |