The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Crosslink Plate.
| Device ID | K911307 |
| 510k Number | K911307 |
| Device Name: | CROSSLINK PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978036373 | K911307 | 000 |
| 00673978036366 | K911307 | 000 |
| 00673978036359 | K911307 | 000 |