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Stryker Spine Maps System

by Howmedica Osteonics

510(k) K032855

Stryker Spine Maps System is a Class II device made by Howmedica Osteonics, cleared under FDA 510(k) K032855 on 10 Dec 2003, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK032855 Date10 Dec 2003ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1886-2009 FDA Unclassified (pre-2012) initiated 1 Jul 2009

    The Trio 3.5MM Hex socket has been reported to break under high stresses.

Timeline

2 dated events

  1. Cleared FDA 510(k) K032855
  2. Recall initiated FDA recalls Z-1886-2009

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  • Withdrawn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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