The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Threvo Anchor, Disposable Driver, Hi-fi Sutures.
| Device ID | K073481 |
| 510k Number | K073481 |
| Device Name: | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Joy Lovett |
| Correspondent | Joy Lovett CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-11 |
| Decision Date | 2008-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854019846 | K073481 | 000 |
| 20845854019839 | K073481 | 000 |