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FDA 510(k)

COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE

K-Number: K033506 · 2004-02-02

ApplicantBiomet, Inc.
Decision Date2004-02-02
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2004-02-02 under 510(k) number K033506. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE?

COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE is a medical device that received FDA 510(k) clearance on 2004-02-02. The listed applicant is Biomet, Inc.. The 510(k) number is K033506.

When did COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE receive FDA 510(k) clearance?

COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE received FDA 510(k) clearance on 2004-02-02, under 510(k) number K033506.

Who is the listed applicant for COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE?

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

What is the FDA product code for COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE?

The FDA product code for COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE is KWS.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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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