EXACTECH 12/14 TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech 12/14 Total Hip System.

Pre-market Notification Details

• Device ID: K041906
• 510k Number: K041906
• Device Name: EXACTECH 12/14 TOTAL HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Gary J Miller
• Correspondent: Gary J Miller; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-07-15
• Decision Date: 2004-09-10
• Summary: summary

NIH GUDID Devices

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