NOVATION 12/14 PRESS-FIT FEMORAL STEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation 12/14 Press-fit Femoral Stem.

Pre-market Notification Details

• Device ID: K042842
• 510k Number: K042842
• Device Name: NOVATION 12/14 PRESS-FIT FEMORAL STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Lisa Simpson
• Correspondent: Lisa Simpson; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: LWJ
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-14
• Decision Date: 2004-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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