MODIFICATION TO: BIOMET HUMERAL CABLE PLATES— 510(k) K013657

Name: FDA 510(k) clearance K013657
Creator: U.S. Food and Drug Administration
Published: 2001-12-03

Substantially Equivalent

Biomet Orthopedics, Inc.

FDA 510(k) clearance K013657 for MODIFICATION TO: BIOMET HUMERAL CABLE PLATES, Substantially Equivalent on 2001-12-03. Applicant: Biomet Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Biomet Orthopedics, Inc.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2001-11-06
Decision date: 2001-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261611 — TDM Large Bone Plate and Screw System2026-10-02
K262649 — Alians Forearm2026-09-28
K261892 — ProRib Fixation System2026-09-23
K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15

More clearances from Biomet Orthopedics, Inc.

view all

K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
K080528 — E-POLY TIBIAL BEARINGS2008-06-17
K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM2008-01-14
K070955 — ACID ETCHED LAG SCREWS2007-10-12
K033355 — LACTOSCREW SCREW ANCHOR2004-06-30

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.