Denali Deformity System
by K2m, LLC
510(k) K052404
Denali Deformity System is a Class II device made by K2m, LLC, cleared under FDA 510(k) K052404 on 23 May 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052404 | Date23 May 2006 | StatusActive |
Official records
- FDA 510(k) database K052404
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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