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FDA 510(k)

VERSA-DIAL HUMERAL HEAD PROSTHESIS

K-Number: K060716 · 2006-06-12

ApplicantBiomet Manufacturing Corp
Decision Date2006-06-12
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERSA-DIAL HUMERAL HEAD PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2006-06-12 under 510(k) number K060716. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSA-DIAL HUMERAL HEAD PROSTHESIS?

VERSA-DIAL HUMERAL HEAD PROSTHESIS is a medical device that received FDA 510(k) clearance on 2006-06-12. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K060716.

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

VERSA-DIAL HUMERAL HEAD PROSTHESIS received FDA 510(k) clearance on 2006-06-12, under 510(k) number K060716.

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

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

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

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

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Related Devices (Code: MBF)

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.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

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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