PRIMALOK FACET FIXATION SYSTEM— 510(k) K102438

Name: FDA 510(k) clearance K102438
Creator: U.S. Food and Drug Administration
Published: 2010-09-30

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K102438 for PRIMALOK FACET FIXATION SYSTEM, Substantially Equivalent on 2010-09-30. Applicant: Osteomed LP. Device class: Unclassified.

Clearance details

Applicant: Osteomed LP
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2010-08-26
Decision date: 2010-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRW

view all

K261209 — Ion-L2026-06-11
K253676 — CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)2026-05-14
K253432 — DiversiVy Facet Screw System2026-03-19
K251714 — Ion-C2026-01-16
K250679 — FFX Facet Fixation System2025-12-04

More clearances from Osteomed LP

view all

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.