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 TOTAL SHOULDER ECCENTRIC HUMERAL HEAD

K-Number: K974044 · 1998-01-22

ApplicantDePuy Orthopaedics, Inc.
Decision Date1998-01-22
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD 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 1998-01-22 under 510(k) number K974044. 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 GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD?

GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K974044.

When did GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD receive FDA 510(k) clearance?

GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD received FDA 510(k) clearance on 1998-01-22, under 510(k) number K974044.

Who is the listed applicant for GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD?

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 TOTAL SHOULDER ECCENTRIC HUMERAL HEAD?

The FDA product code for GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD is KWS.

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: 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.

↑