The following data is part of a premarket notification filed by Danek Group, Inc. with the FDA for Dyna-lok Anterior Plating System.
| Device ID | K936307 |
| 510k Number | K936307 |
| Device Name: | DYNA-LOK ANTERIOR PLATING SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DANEK GROUP, INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Richard W Treharne,ph.d |
| Correspondent | Richard W Treharne,ph.d DANEK GROUP, INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| 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 | 1993-08-23 |
| Decision Date | 1995-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978150864 | K936307 | 000 |
| 00673978150857 | K936307 | 000 |
| 00673978130972 | K936307 | 000 |
| 00673978130965 | K936307 | 000 |
| 00673978130958 | K936307 | 000 |