The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Dyna-lok Classic Spinal System.
| Device ID | K001532 |
| 510k Number | K001532 |
| Device Name: | DYNA-LOK CLASSIC SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne, Ph.d. |
| Correspondent | Richard W Treharne, Ph.d. MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2000-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978950525 | K001532 | 000 |
| 00673978950297 | K001532 | 000 |
| 00673978950303 | K001532 | 000 |
| 00673978950341 | K001532 | 000 |
| 00673978950358 | K001532 | 000 |
| 00673978950365 | K001532 | 000 |
| 00673978950372 | K001532 | 000 |
| 00673978950396 | K001532 | 000 |
| 00673978950402 | K001532 | 000 |
| 00673978950419 | K001532 | 000 |
| 00673978950426 | K001532 | 000 |
| 00673978950501 | K001532 | 000 |
| 00673978950518 | K001532 | 000 |
| 00673978950259 | K001532 | 000 |