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)

UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

K-Number: K000827 · 2000-06-23

ApplicantWalter Abendschein, M.D.
Decision Date2000-06-23
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED is the device name listed in this FDA 510(k) record. The listed applicant is Walter Abendschein, M.D.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K000827. 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 UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED?

UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Walter Abendschein, M.D.. The 510(k) number is K000827.

When did UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED receive FDA 510(k) clearance?

UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED received FDA 510(k) clearance on 2000-06-23, under 510(k) number K000827.

Who is the listed applicant for UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED?

The FDA 510(k) record lists Walter Abendschein, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED?

The FDA product code for UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED 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 Walter Abendschein, M.D. 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.

K011603VHS PEDIATRIC HIP SCREW SYSTEMK002184COD COMPRESSION OSTEOTOMY DEVICEK991806VHS SUPRACONDYLAR PLATE SYSTEMK964880VARI-ANGLE HIP SCREW (VHS) SYSTEM

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.

↑