Exactech® Alteon® HA Femoral Stem

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

EXACTECH INC

The following data is part of a premarket notification filed by Exactech Inc with the FDA for Exactech® Alteon® Ha Femoral Stem.

Pre-market Notification Details

• Device ID: K162732
• 510k Number: K162732
• Device Name: Exactech® Alteon® HA Femoral Stem
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: EXACTECH INC 2320 NW 66TH COURT Gainesville, FL 32653
• Contact: Thomas Mcnamara
• Correspondent: Thomas Mcnamara; EXACTECH INC 2320 NW 66TH COURT Gainesville, FL 32653
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-29
• Decision Date: 2017-04-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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