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FDA 510(k)

VERSA-DIAL HUMERAL HEAD

K-Number: K040610 · 2004-06-04

ApplicantBiomet Manufacturing, Inc.
Decision Date2004-06-04
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERSA-DIAL HUMERAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040610. 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 VERSA-DIAL HUMERAL HEAD?

VERSA-DIAL HUMERAL HEAD is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K040610.

When did VERSA-DIAL HUMERAL HEAD receive FDA 510(k) clearance?

VERSA-DIAL HUMERAL HEAD received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040610.

Who is the listed applicant for VERSA-DIAL HUMERAL HEAD?

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

What is the FDA product code for VERSA-DIAL HUMERAL HEAD?

The FDA product code for VERSA-DIAL HUMERAL HEAD is KWS.

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Other records listing Biomet Manufacturing, 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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEM

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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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