The following data is part of a premarket notification filed by Danek Group, Inc. with the FDA for Gdlh Variable Angle Connector.
| Device ID | K934582 |
| 510k Number | K934582 |
| Device Name: | GDLH VARIABLE ANGLE CONNECTOR |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-23 |
| Decision Date | 1994-06-21 |