Xia Spinal System
510(k) K022160
Xia Spinal System is a Class II device made by Howmedica Osteonics, cleared under FDA 510(k) K022160 on 1 Aug 2002, 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 | NumberK022160 | Date1 Aug 2002 | StatusActive |
Official records
- FDA 510(k) database K022160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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- SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM by Synthes Spine
- MODIFICATION TO STRYKER SPINE OASYS SYSTEM by Stryker Spine
- SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM by TRINITY ORTHOPEDICS, LLC