MODIFICATION TO ORIA TOP CLIP SYSTEM

Orthosis, Spinal Pedicle Fixation

ORTHOTEC, L.L.C.

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

Pre-market Notification Details

• Device ID: K040346
• 510k Number: K040346
• Device Name: MODIFICATION TO ORIA TOP CLIP SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• 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: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-12
• Decision Date: 2004-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840996119061	K040346	000
00840996119214	K040346	000
00840996119221	K040346	000
00840996119238	K040346	000
00840996119245	K040346	000
00840996119252	K040346	000
00840996119269	K040346	000
00840996119276	K040346	000
00840996119283	K040346	000
00840996119290	K040346	000
00840996119306	K040346	000
00840996119313	K040346	000
00840996119320	K040346	000
00840996119207	K040346	000
00840996119191	K040346	000
00840996119078	K040346	000
00840996119085	K040346	000
00840996119092	K040346	000
00840996119108	K040346	000
00840996119115	K040346	000
00840996119122	K040346	000
00840996119139	K040346	000
00840996119146	K040346	000
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00840996119160	K040346	000
00840996119177	K040346	000
00840996119184	K040346	000
00840996119337	K040346	000
00840996119344	K040346	000
00840996119498	K040346	000
00840996119504	K040346	000
00840996131766	K040346	000
00840996131773	K040346	000
00840996131780	K040346	000
00840996131797	K040346	000
00840996131803	K040346	000
00840996131810	K040346	000
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00840996131834	K040346	000
00840996131841	K040346	000
00840996131858	K040346	000
00840996119481	K040346	000
00840996119474	K040346	000
00840996119351	K040346	000
00840996119368	K040346	000
00840996119375	K040346	000
00840996119382	K040346	000
00840996119399	K040346	000
00840996119405	K040346	000
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00840996131865	K040346	000