The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Microfracture Instrument Sterilization Tray.
| Device ID | K080531 |
| 510k Number | K080531 |
| Device Name: | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-26 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854027732 | K080531 | 000 |
| 10845854082362 | K080531 | 000 |