The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Sofamor Orthopaedic Instruments.
| Device ID | K933242 |
| 510k Number | K933242 |
| Device Name: | SOFAMOR ORTHOPAEDIC INSTRUMENTS |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Brian Gooden |
| Correspondent | Brian Gooden DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-02 |
| Decision Date | 1994-01-28 |