ZIMMER NEXEL TOTAL ELBOW

Prosthesis, Elbow, Constrained, Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Nexel Total Elbow.

Pre-market Notification Details

• Device ID: K123862
• 510k Number: K123862
• Device Name: ZIMMER NEXEL TOTAL ELBOW
• Classification: Prosthesis, Elbow, Constrained, Cemented
• Applicant: ZIMMER, INC. 1800 WEST CENTER STREET Warsaw, IN 46580
• Contact: Joanna L Surma
• Correspondent: Joanna L Surma; ZIMMER, INC. 1800 WEST CENTER STREET Warsaw, IN 46580
• Product Code: JDC
• CFR Regulation Number: 888.3150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-14
• Decision Date: 2013-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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