The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Luque V Spinal System.
| Device ID | K921256 |
| 510k Number | K921256 |
| Device Name: | LUQUE V 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 | 1992-03-16 |
| Decision Date | 1993-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490991209 | K921256 | 000 |
| 00673978050980 | K921256 | 000 |
| 00673978056258 | K921256 | 000 |
| 00673978951683 | K921256 | 000 |
| 00673978953199 | K921256 | 000 |
| 00681490990769 | K921256 | 000 |
| 00681490990783 | K921256 | 000 |
| 00681490990820 | K921256 | 000 |
| 00681490990844 | K921256 | 000 |
| 00681490991018 | K921256 | 000 |
| 00681490991063 | K921256 | 000 |
| 00681490991117 | K921256 | 000 |
| 00681490991124 | K921256 | 000 |
| 00681490991155 | K921256 | 000 |
| 00681490991193 | K921256 | 000 |
| 00721902870408 | K921256 | 000 |