Synchro-Medical TIGER TRACK Screw System

Screw, Fixation, Bone

Synchro Medical

The following data is part of a premarket notification filed by Synchro Medical with the FDA for Synchro-medical Tiger Track Screw System.

Pre-market Notification Details

• Device ID: K151241
• 510k Number: K151241
• Device Name: Synchro-Medical TIGER TRACK Screw System
• Classification: Screw, Fixation, Bone
• Applicant: Synchro Medical 21 Rue Des Merisiers Wettolsheim Les Erlen, FR Fr-68920
• Contact: Danilo Campani
• Correspondent: Mark F. Schenk; Mark F Schenk Consulting 505 Berks Place West Lawn, PA 19609
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-11
• Decision Date: 2015-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03701091001125	K151241	000
03701091000951	K151241	000
03701091000944	K151241	000
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