RECON System

Plate, Fixation, Bone

NORMED MEDIZIN-TECHNIK GMBH

The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Recon System.

Pre-market Notification Details

• Device ID: K151407
• 510k Number: K151407
• Device Name: RECON System
• Classification: Plate, Fixation, Bone
• Applicant: NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 Tuttlingen, DE D-78532
• Contact: Arne Briest
• Correspondent: Arne Briest; NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 Tuttlingen, DE D-78532
• Product Code: HRS
• Subsequent Product Code: HTN
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-26
• Decision Date: 2015-08-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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