MODIFICATION TO SCORPIO NRG KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Modification To Scorpio Nrg Knee System.

Pre-market Notification Details

• Device ID: K071991
• 510k Number: K071991
• Device Name: MODIFICATION TO SCORPIO NRG KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Contact: Patricia Setti-laperch
• Correspondent: Patricia Setti-laperch; HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-20
• Decision Date: 2007-08-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327030877	K071991	000
07613327030747	K071991	000
07613327030730	K071991	000
07613327030723	K071991	000
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07613327030761	K071991	000
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07613327030792	K071991	000
07613327030785	K071991	000
07613327030662	K071991	000
07613327030655	K071991	000
07613327030518	K071991	000
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07613327030464	K071991	000
07613327030457	K071991	000
07613327030433	K071991	000
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07613327030525	K071991	000
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07613327030563	K071991	000
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07613327030884	K071991	000
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07613327031188	K071991	000
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07613327030891	K071991	000