FacetBRIDGE® System
510(k) K161798
FacetBRIDGE® System is a device classified as Unclassified made by LDR Spine Usa, Inc., cleared under FDA 510(k) K161798 on 4 Aug 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 | NumberK161798 | Date4 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161798
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MRW
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
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- Ion Facet Screw System by SURGENTEC LLC
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- RESOLUTE FACET SCREW SYSTEM by NEUROSTRUCTURES, INC
- AERO MIS Facet Fusion System by AURORA SPINE, INC.