The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Paragon Posterior Spinal System.
| Device ID | K920546 |
| 510k Number | K920546 |
| Device Name: | PARAGON POSTERIOR SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-06 |
| Decision Date | 1993-01-21 |