Comprehensive Nano Stemless Shoulder

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

Biomet Manufacturing Corp

The following data is part of a premarket notification filed by Biomet Manufacturing Corp with the FDA for Comprehensive Nano Stemless Shoulder.

Pre-market Notification Details

• Device ID: K182516
• 510k Number: K182516
• Device Name: Comprehensive Nano Stemless Shoulder
• Classification: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
• Applicant: Biomet Manufacturing Corp 56 East Bell Drive Warsaw, IN 46582
• Contact: Jeff Gensler
• Correspondent: Dalene Binkley; Biomet Manufacturing Corp 56 East Bell Drive Warsaw, IN 46582
• Product Code: PKC
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-13
• Decision Date: 2019-04-22

NIH GUDID Devices

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