OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM— 510(k) K111176

Clearance details

Applicant

Osteomed LP

Product code

Code GWO

Device class

Class 2

Regulation

21 CFR 882.5320

Advisory panel

Neurology

Date received

2011-04-27

Decision date

2011-08-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Addison, TX, US

• K262874 — CraniUS Plate2026-09-11
• K261058 — CraniUS Plate2026-07-29
• K250297 — TECHFIT Patient-Specific Cranial System2025-10-27
• K250334 — Fusion Craniofacial Implant; Fusion Skull Implant2025-07-25
• K231834 — VSP PEEK Cranial Implant2024-04-04

• K143338 — Argulated Locking Plates2015-04-01
• K133691 — EXTRIMILOCK ANKLE PLATING SYSTEM2014-02-24
• K131445 — OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM2013-06-18
• K123885 — OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR2013-06-03
• K123207 — PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM2012-11-29

Malfunction

583

Total

583

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2107-2023 — REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileClass II·Ongoing·Osteomed, LLC·20230531
• Z-2108-2023 — REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, SterileClass II·Ongoing·Osteomed, LLC·20230531

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111176.