The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Universal Drive System.
| Device ID | K981269 |
| 510k Number | K981269 |
| Device Name: | UNIVERSAL DRIVE SYSTEM |
| Classification | Arthroscope |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Wedeman |
| Correspondent | Carol A Wedeman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-06-24 |
| Summary: | summary |