The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Ray Sacral Fixation System.
| Device ID | K904520 |
| 510k Number | K904520 |
| Device Name: | RAY SACRAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Frank Lewis |
| Correspondent | Frank Lewis DANEK MEDICAL, INC. 3092 DIRECTOR'S 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 | 1990-10-03 |
| Decision Date | 1991-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978045382 | K904520 | 000 |
| 00673978041698 | K904520 | 000 |
| 00673978041681 | K904520 | 000 |
| 00673978041674 | K904520 | 000 |
| 00673978041667 | K904520 | 000 |
| 00673978041650 | K904520 | 000 |
| 00673978039763 | K904520 | 000 |
| 00673978039756 | K904520 | 000 |
| 00673978039749 | K904520 | 000 |
| 00673978039732 | K904520 | 000 |
| 00673978039725 | K904520 | 000 |
| 00673978039213 | K904520 | 000 |
| 00673978039206 | K904520 | 000 |
| 00673978039190 | K904520 | 000 |
| 00673978041704 | K904520 | 000 |
| 00673978041711 | K904520 | 000 |
| 00673978041728 | K904520 | 000 |
| 00673978041865 | K904520 | 000 |
| 00673978041858 | K904520 | 000 |
| 00673978041841 | K904520 | 000 |
| 00673978041834 | K904520 | 000 |
| 00673978041827 | K904520 | 000 |
| 00673978041810 | K904520 | 000 |
| 00673978041803 | K904520 | 000 |
| 00673978041780 | K904520 | 000 |
| 00673978041773 | K904520 | 000 |
| 00673978041766 | K904520 | 000 |
| 00673978041759 | K904520 | 000 |
| 00673978041742 | K904520 | 000 |
| 00673978041735 | K904520 | 000 |
| 00673978036502 | K904520 | 000 |