The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Spine Fixation.
| Device ID | K943827 |
| 510k Number | K943827 |
| Device Name: | SPINE FIXATION |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Rick Treharne |
| Correspondent | Rick Treharne DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1996-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978094663 | K943827 | 000 |
| 00673978062884 | K943827 | 000 |
| 00673978062877 | K943827 | 000 |
| 00673978062860 | K943827 | 000 |
| 00673978062853 | K943827 | 000 |
| 00673978062846 | K943827 | 000 |
| 00673978062839 | K943827 | 000 |
| 00673978062822 | K943827 | 000 |
| 00673978062815 | K943827 | 000 |
| 00673978062525 | K943827 | 000 |
| 00673978062518 | K943827 | 000 |
| 00673978062501 | K943827 | 000 |
| 00673978062891 | K943827 | 000 |
| 00673978062907 | K943827 | 000 |
| 00673978094656 | K943827 | 000 |
| 00673978074054 | K943827 | 000 |
| 00673978062990 | K943827 | 000 |
| 00673978062983 | K943827 | 000 |
| 00673978062976 | K943827 | 000 |
| 00673978062969 | K943827 | 000 |
| 00673978062952 | K943827 | 000 |
| 00673978062945 | K943827 | 000 |
| 00673978062938 | K943827 | 000 |
| 00673978062921 | K943827 | 000 |
| 00673978062914 | K943827 | 000 |
| 00673978062471 | K943827 | 000 |