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FDA 510(k)

MODIFICATION TO: BIOMET HUMERAL CABLE PLATES

K-Number: K013657 · 2001-12-03

ApplicantBiomet Orthopedics, Inc.
Decision Date2001-12-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: BIOMET HUMERAL CABLE PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K013657. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: BIOMET HUMERAL CABLE PLATES?

MODIFICATION TO: BIOMET HUMERAL CABLE PLATES is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K013657.

When did MODIFICATION TO: BIOMET HUMERAL CABLE PLATES receive FDA 510(k) clearance?

MODIFICATION TO: BIOMET HUMERAL CABLE PLATES received FDA 510(k) clearance on 2001-12-03, under 510(k) number K013657.

Who is the listed applicant for MODIFICATION TO: BIOMET HUMERAL CABLE PLATES?

The FDA 510(k) record lists Biomet Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: BIOMET HUMERAL CABLE PLATES?

The FDA product code for MODIFICATION TO: BIOMET HUMERAL CABLE PLATES is HRS.

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Other records listing Biomet Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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