CrossRoads Screw System

Screw, Fixation, Bone

ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM

The following data is part of a premarket notification filed by Orthodiscovery Group Llc (d.b.a. Crossroads Extrem with the FDA for Crossroads Screw System.

Pre-market Notification Details

• Device ID: K143039
• 510k Number: K143039
• Device Name: CrossRoads Screw System
• Classification: Screw, Fixation, Bone
• Applicant: ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM 458 DISTRIBUTION PKWY Collierville, TN 38017
• Contact: Vernon Hartdegen
• Correspondent: Vernon Hartdegen; ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM 458 DISTRIBUTION PKWY Collierville, TN 38017
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-22
• Decision Date: 2015-01-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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