The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Osprey Drill System.
| Device ID | K080444 |
| 510k Number | K080444 |
| Device Name: | CONMED LINVATEC OSPREY DRILL SYSTEM |
| Classification | Motor, Drill, Electric |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Sue F Dauterman |
| Correspondent | Sue F Dauterman CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-04-02 |
| Summary: | summary |