GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.

The following data is part of a premarket notification filed by Global Orthopaedic Technology, Usa, Inc. with the FDA for Global Resurfacing Unicompartmental Knee System.

Pre-market Notification Details

• Device ID: K051721
• 510k Number: K051721
• Device Name: GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT Oviedo, FL 32765 -5018
• Contact: Carl Knobloch
• Correspondent: Carl Knobloch; GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT Oviedo, FL 32765 -5018
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-06-27
• Decision Date: 2005-10-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09340499005195	K051721	000
09340499005317	K051721	000
09340499005324	K051721	000
09340499005331	K051721	000
09340499005348	K051721	000
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09340499005300	K051721	000
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09340499005218	K051721	000
09340499005225	K051721	000
09340499005232	K051721	000
09340499005249	K051721	000
09340499005256	K051721	000
09340499005263	K051721	000
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09340499005409	K051721	000
09340499005416	K051721	000
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09340499022628	K051721	000
09340499022635	K051721	000
09340499022642	K051721	000
09340499022659	K051721	000
09340499022666	K051721	000
09340499022673	K051721	000
09340499022680	K051721	000
09340499005522	K051721	000
09340499005515	K051721	000
09340499005423	K051721	000
09340499005430	K051721	000
09340499005447	K051721	000
09340499005454	K051721	000
09340499005461	K051721	000
09340499005478	K051721	000
09340499005485	K051721	000
09340499005492	K051721	000
09340499005508	K051721	000
09340499022697	K051721	000