Exactech® Equinoxe® Preserve Stem

Shoulder Prosthesis, Reverse Configuration

EXACTECH INC

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

Pre-market Notification Details

• Device ID: K162726
• 510k Number: K162726
• Device Name: Exactech® Equinoxe® Preserve Stem
• Classification: Shoulder Prosthesis, Reverse Configuration
• 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: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-29
• Decision Date: 2017-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862579997	K162726	000
10885862080677	K162726	000
10885862530974	K162726	000
10885862530943	K162726	000
10885862530936	K162726	000
10885862530929	K162726	000
10885862530912	K162726	000
10885862530905	K162726	000
10885862530899	K162726	000
10885862530882	K162726	000
10885862530875	K162726	000
10885862534200	K162726	000
10885862582829	K162726	000
10885862577498	K162726	000
10885862577597	K162726	000
10885862577580	K162726	000
10885862577573	K162726	000
10885862577566	K162726	000
10885862577559	K162726	000
10885862577542	K162726	000
10885862577535	K162726	000
10885862577528	K162726	000
10885862577511	K162726	000
10885862577504	K162726	000
10885862530950	K162726	000