The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Advanced Turbo Drive System.
| Device ID | K050519 |
| 510k Number | K050519 |
| Device Name: | ADVANCED TURBO DRIVE SYSTEM |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2005-05-17 |
| Summary: | summary |