Normed Extremity Titanium Hand and Small Fragment System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K011118 ↗

FDA Product Code

HRS

FDA applicant

Osteomedics

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Normed Titanium Calcaneus Plating with Locking Screw System

  Class II

  FDA 510(k) K022324 Active Cleared 17 Sep 2002

• Normed Titanium Rondo Fix Fusion Plates and Screw System

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  FDA 510(k) K022323 Active Cleared 9 Sep 2002

• Normed Mini External Fixator System

  Class II

  FDA 510(k) K022230 Active Cleared 10 Sep 2002

• Normed Mandibular Fixation System

  Class II

  FDA 510(k) K010118 Active Cleared 14 Aug 2001

• Normed Bone Transport Distraction Device

  Class II

  FDA 510(k) K021341 Active Cleared 1 Aug 2002

• Normed Titanium Osteotomy Plating System

  Class II

  FDA 510(k) K022325 Active Cleared 9 Sep 2002

See all devices from Osteomedics, Inc. →