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)

HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

K-Number: K060127 · 2006-03-16

ApplicantArthrosurface, Inc.
Decision Date2006-03-16
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2006-03-16 under 510(k) number K060127. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS?

HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K060127.

When did HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS receive FDA 510(k) clearance?

HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS received FDA 510(k) clearance on 2006-03-16, under 510(k) number K060127.

Who is the listed applicant for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS?

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 HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS?

The FDA product code for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS is KRR.

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: KRR)

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.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.K160461Arthrex iBalance BiCompartmental Arthroplasty 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.

↑