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FDA 510(k)

GLOBAL FX POROUS-COATED HUMERAL STEM

K-Number: K011099 · 2001-07-06

ApplicantDePuy Orthopaedics, Inc.
Decision Date2001-07-06
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL FX POROUS-COATED HUMERAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2001-07-06 under 510(k) number K011099. 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 GLOBAL FX POROUS-COATED HUMERAL STEM?

GLOBAL FX POROUS-COATED HUMERAL STEM is a medical device that received FDA 510(k) clearance on 2001-07-06. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K011099.

When did GLOBAL FX POROUS-COATED HUMERAL STEM receive FDA 510(k) clearance?

GLOBAL FX POROUS-COATED HUMERAL STEM received FDA 510(k) clearance on 2001-07-06, under 510(k) number K011099.

Who is the listed applicant for GLOBAL FX POROUS-COATED HUMERAL STEM?

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

What is the FDA product code for GLOBAL FX POROUS-COATED HUMERAL STEM?

The FDA product code for GLOBAL FX POROUS-COATED HUMERAL STEM is MBF.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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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