The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for D4000 Drive System; D4000a Drive System With Irrigation.
| Device ID | K130497 |
| 510k Number | K130497 |
| Device Name: | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION |
| Classification | Motor, Drill, Electric |
| Applicant | LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Contact | Jonathan Werner |
| Correspondent | Jonathan Werner LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Product Code | HBC |
| Subsequent Product Code | ERL |
| Subsequent Product Code | GEY |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-26 |
| Decision Date | 2013-03-29 |
| Summary: | summary |