ZIMMER TRABECULAR METAL TOTAL ANKLE

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

ZIMMER, INC.

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

Pre-market Notification Details

• Device ID: K120906
• 510k Number: K120906
• Device Name: ZIMMER TRABECULAR METAL TOTAL ANKLE
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Rebecca Dill
• Correspondent: Rebecca Dill; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-26
• Decision Date: 2012-08-24
• Summary: summary

NIH GUDID Devices

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