Xia Spinal System
510(k) K013823
Xia Spinal System is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K013823 on 19 Dec 2001, 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 | NumberK013823 | Date19 Dec 2001 | StatusActive |
Official records
- FDA 510(k) database K013823
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- Withdrawn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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