The following data is part of a premarket notification filed by K2m, Llc with the FDA for Denali Deformity System.
| Device ID | K052404 |
| 510k Number | K052404 |
| Device Name: | DENALI DEFORMITY SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | K2M, LLC 751 MILLER DRIVE SE, SUITE F1 Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, LLC 751 MILLER DRIVE SE, SUITE F1 Leesburg, VA 20175 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-01 |
| Decision Date | 2006-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857011502 | K052404 | 000 |
| 10888857011489 | K052404 | 000 |
| 10888857011465 | K052404 | 000 |
| 10888857008892 | K052404 | 000 |
| 10888857007499 | K052404 | 000 |
| 10888857011526 | K052404 | 000 |