GMK SPHERE

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

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Sphere.

Pre-market Notification Details

• Device ID: K121416
• 510k Number: K121416
• Device Name: GMK SPHERE
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Contact: Adam Gross
• Correspondent: Adam Gross; MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-11
• Decision Date: 2012-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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