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FacetBRIDGE System

by Ldr Spine USA

510(k) K152137

FacetBRIDGE System is a device classified as Unclassified made by Ldr Spine USA, cleared under FDA 510(k) K152137 on 25 Jan 2016, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152137 Date25 Jan 2016ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MRW
Device class
U
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MRW (System, Facet Screw Spinal Device).

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