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Modification to Opus Spinal System

by Howmedica Osteonics Corp.

510(k) K014229

Modification to Opus Spinal System is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K014229 on 25 Jan 2002, 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 · Special NumberK014229 Date25 Jan 2002ClearedStatusActive

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  • Withdrawn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
MNH
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).

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