Exactech® Novation® Crown Cup®

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® Novation® Crown Cup®.

Pre-market Notification Details

• Device ID: K141960
• 510k Number: K141960
• Device Name: Exactech® Novation® Crown Cup®
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Thomas Mcnamara
• Correspondent: Thomas Mcnamara; 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: MBL
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-18
• Decision Date: 2015-09-03
• Summary: summary