The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Bone Graft Washer, Model 9090114 - 9090118.
| Device ID | K994122 |
| 510k Number | K994122 |
| Device Name: | BONE GRAFT WASHER, MODEL 9090114 - 9090118 |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-07 |
| Decision Date | 2000-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994543578 | K994122 | 000 |
| 00613994473394 | K994122 | 000 |
| 00613994391971 | K994122 | 000 |
| 00613994391964 | K994122 | 000 |
| 00673978958934 | K994122 | 000 |
| 00673978958910 | K994122 | 000 |