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, UNCEMENT HUMERAL HEMI-SHOUL

K-Number: K911686 · 1991-07-15

ApplicantDepuy, Inc.
Decision Date1991-07-15
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1991-07-15 under 510(k) number K911686. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL?

GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL is a medical device that received FDA 510(k) clearance on 1991-07-15. The listed applicant is Depuy, Inc.. The 510(k) number is K911686.

When did GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL receive FDA 510(k) clearance?

GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL received FDA 510(k) clearance on 1991-07-15, under 510(k) number K911686.

Who is the listed applicant for GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL?

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

What is the FDA product code for GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL?

The FDA product code for GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL is HSD.

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, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

View all 303 devices →

Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, 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.

↑