SALVATION® External Fixation System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Salvation® External Fixation System.

Pre-market Notification Details

• Device ID: K152045
• 510k Number: K152045
• Device Name: SALVATION® External Fixation System
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117
• Contact: Jeanine Redden
• Correspondent: Jeanine Redden; WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-23
• Decision Date: 2015-08-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840420185495	K152045	000
00889797064682	K152045	000
00889797064675	K152045	000
00889797064651	K152045	000
00889797064644	K152045	000
00889797064637	K152045	000
00889797064569	K152045	000
00889797064552	K152045	000
00889797064545	K152045	000
00889797064699	K152045	000
00889797064828	K152045	000
00889797064842	K152045	000
00840420185297	K152045	000
00889797071758	K152045	000
00889797071741	K152045	000
00889797071734	K152045	000
00889797064880	K152045	000
00889797064873	K152045	000
00889797064866	K152045	000
00889797064859	K152045	000
00889797064538	K152045	000