Equinoxe Mega Prosthesis

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Equinoxe Mega Prosthesis.

Pre-market Notification Details

• Device ID: K143659
• 510k Number: K143659
• Device Name: Equinoxe Mega Prosthesis
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: EXACTECH, INC. 2320 Northwest 66th Court Gainesville, FL 32653
• Contact: Thomas Mcnamara
• Correspondent: Thomas Mcnamara; EXACTECH, INC. 2320 Northwest 66th Court Gainesville, FL 32653
• Product Code: KWT
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: PHX
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-23
• Decision Date: 2015-04-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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