ORIA SPINAL CLIP SYSTEM

Appliance, Fixation, Spinal Interlaminal

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Spinal Clip System.

Pre-market Notification Details

• Device ID: K021679
• 510k Number: K021679
• Device Name: ORIA SPINAL CLIP SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills, CA 90212
• Contact: Patrick Bertranou
• Correspondent: Patrick Bertranou; ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills, CA 90212
• Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-21
• Decision Date: 2002-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840996120937	K021679	000
00840996121088	K021679	000
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