ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch L-series Cemented Femoral Stem, Model L-series Cemented.

Pre-market Notification Details

• Device ID: K001335
• 510k Number: K001335
• Device Name: ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• 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: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-27
• Decision Date: 2000-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862016256	K001335	000
10885862016249	K001335	000
10885862016232	K001335	000
10885862016225	K001335	000