LEFORTE SYSTEM BONE PLATE & SCREW

Plate, Bone

ARKIN CONSULTING GROUP

The following data is part of a premarket notification filed by Arkin Consulting Group with the FDA for Leforte System Bone Plate & Screw.

Pre-market Notification Details

• Device ID: K112457
• 510k Number: K112457
• Device Name: LEFORTE SYSTEM BONE PLATE & SCREW
• Classification: Plate, Bone
• Applicant: ARKIN CONSULTING GROUP 1733 CANTON LANE Marietta, GA 30062 -2679
• Contact: Paul Sumner
• Correspondent: Paul Sumner; ARKIN CONSULTING GROUP 1733 CANTON LANE Marietta, GA 30062 -2679
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-26
• Decision Date: 2012-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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