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Roi Fusion Rods & Plates

by Reiley Orthopaedics, Inc.

510(k) K051309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051309 Date11 Jul 2005ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2589-2011 FDA Unclassified (pre-2012) initiated 20 Apr 2011
    • Terminated Z-2590-2011 FDA Unclassified (pre-2012) initiated 20 Apr 2011

    Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent