Spinal Elements' Spinous Process Plate System
510(k) K160465
Spinal Elements' Spinous Process Plate System is a Class II device made by Spinal Elements, Inc., cleared under FDA 510(k) K160465 on 28 Jul 2016, 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 | NumberK160465 | Date28 Jul 2016 | StatusActive |
Official records
- FDA 510(k) database K160465
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PEK
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code PEK (Spinous Process Plate).
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