The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Bio-mini Revo Suture Anchor.
| Device ID | K053561 |
| 510k Number | K053561 |
| Device Name: | BIO-MINI REVO SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul 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 | 2005-12-21 |
| Decision Date | 2006-02-23 |
| Summary: | summary |