Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GLOBAL AP POROUS COATED HUMERAL STEM

K-Number: K063652 · 2007-02-01

ApplicantDePuy Orthopaedics, Inc.
Decision Date2007-02-01
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL AP 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 2007-02-01 under 510(k) number K063652. 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 AP POROUS COATED HUMERAL STEM?

GLOBAL AP POROUS COATED HUMERAL STEM is a medical device that received FDA 510(k) clearance on 2007-02-01. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K063652.

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

GLOBAL AP POROUS COATED HUMERAL STEM received FDA 510(k) clearance on 2007-02-01, under 510(k) number K063652.

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing DePuy Orthopaedics, 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.

K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

View all 206 devices →

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.

↑