The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Danek Tissue Cutting And Removal System.
| Device ID | K922486 |
| 510k Number | K922486 |
| Device Name: | DANEK TISSUE CUTTING AND REMOVAL SYSTEM |
| Classification | Arthroscope |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Bailey Lipscomb |
| Correspondent | Bailey Lipscomb SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1993-10-12 |