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)

GRS GLENOID RESURFACING SYSTEM

K-Number: K091196 · 2009-10-27

ApplicantArthrosurface, Inc.
Decision Date2009-10-27
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GRS GLENOID RESURFACING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2009-10-27 under 510(k) number K091196. 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 GRS GLENOID RESURFACING SYSTEM?

GRS GLENOID RESURFACING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-27. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K091196.

When did GRS GLENOID RESURFACING SYSTEM receive FDA 510(k) clearance?

GRS GLENOID RESURFACING SYSTEM received FDA 510(k) clearance on 2009-10-27, under 510(k) number K091196.

Who is the listed applicant for GRS GLENOID RESURFACING SYSTEM?

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

What is the FDA product code for GRS GLENOID RESURFACING SYSTEM?

The FDA product code for GRS GLENOID RESURFACING SYSTEM 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 Arthrosurface, 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.

K203375OVOMotion Reverse Shoulder Arthroplasty SystemK200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemK190261BOSS Toe Fixation SystemK181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemK173964OVOMotion Shoulder Arthroplasty SystemK172383Arthrosurface Bone Screws

View all 21 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.

↑