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FDA 510(k)

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM

K-Number: K112905 · 2012-05-24

ApplicantBiomet Orthopedics, LLC
Decision Date2012-05-24
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, LLC. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K112905. 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 COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM?

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Biomet Orthopedics, LLC. The 510(k) number is K112905.

When did COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM receive FDA 510(k) clearance?

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM received FDA 510(k) clearance on 2012-05-24, under 510(k) number K112905.

Who is the listed applicant for COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM?

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

What is the FDA product code for COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM?

The FDA product code for COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM 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

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

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