OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM— 510(k) K131445

Name: FDA 510(k) clearance K131445
Creator: U.S. Food and Drug Administration
Published: 2013-06-18

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K131445 for OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM, Substantially Equivalent on 2013-06-18. Applicant: Osteomed LP. Device class: 2.

Clearance details

Applicant: Osteomed LP
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2013-05-20
Decision date: 2013-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

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K261511 — Xpert Ankle2026-07-28

More clearances from Osteomed LP

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K143338 — Argulated Locking Plates2015-04-01
K133691 — EXTRIMILOCK ANKLE PLATING SYSTEM2014-02-24
K123885 — OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR2013-06-03
K123207 — PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM2012-11-29
K120015 — OSTEOMED WRIST PLATING SYSTEM2012-04-24

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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 →

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