OTELO LL

Retractor

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Otelo Ll.

Pre-market Notification Details

• Device ID: K151104
• 510k Number: K151104
• Device Name: OTELO LL
• Classification: Retractor
• Applicant: SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneve, CH 1215
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneve, CH 1215
• Product Code: GAD
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-24
• Decision Date: 2016-01-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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