MySpine Pedicle Screw Placement Guides - LP

Orthosis, Spinal Pedicle Fixation

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myspine Pedicle Screw Placement Guides - Lp.

Pre-market Notification Details

• Device ID: K153273
• 510k Number: K153273
• Device Name: MySpine Pedicle Screw Placement Guides - LP
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch 6874
• Contact: Michael G Loiterman
• Correspondent: Roshana Ahmed; Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington, KY 40504
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-12
• Decision Date: 2016-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030877605	K153273	000
07630030877476	K153273	000
07630030877469	K153273	000
07630030877452	K153273	000
07630030877445	K153273	000
07630030877438	K153273	000
07630030877421	K153273	000
07630040716888	K153273	000
07630040716864	K153273	000
07630040716840	K153273	000
07630040716826	K153273	000
07630030877483	K153273	000
07630030877490	K153273	000
07630030877599	K153273	000
07630030877582	K153273	000
07630030877575	K153273	000
07630030877568	K153273	000
07630030877551	K153273	000
07630030877544	K153273	000
07630030877537	K153273	000
07630030877520	K153273	000
07630030877513	K153273	000
07630030877506	K153273	000
07630040716802	K153273	000
07630040716789	K153273	000
07630971262706	K153273	000
07630971262690	K153273	000
07630971262683	K153273	000
07630971257801	K153273	000
07630971257795	K153273	000
07630971257788	K153273	000
07630971257771	K153273	000
07630040716529	K153273	000
07630040716505	K153273	000
07630040716482	K153273	000
07630971262713	K153273	000
07630040716567	K153273	000
07630040716765	K153273	000
07630040716741	K153273	000
07630040716727	K153273	000
07630040716703	K153273	000
07630040716680	K153273	000
07630040716666	K153273	000
07630040716642	K153273	000
07630040716628	K153273	000
07630040716604	K153273	000
07630040716581	K153273	000
07630040716468	K153273	000
07630030877612	K153273	000
07630030878091	K153273	000
07630030877964	K153273	000
07630030877957	K153273	000
07630030877940	K153273	000
07630030877933	K153273	000
07630030877926	K153273	000
07630030877919	K153273	000
07630030877902	K153273	000
07630030877896	K153273	000
07630030877889	K153273	000
07630030877872	K153273	000
07630030877971	K153273	000
07630030877988	K153273	000
07630030878084	K153273	000
07630030878077	K153273	000
07630030878060	K153273	000
07630030878053	K153273	000
07630030878046	K153273	000
07630030878039	K153273	000
07630030878022	K153273	000
07630030878015	K153273	000
07630030878008	K153273	000
07630030877995	K153273	000
07630030877865	K153273	000
07630030877858	K153273	000
07630030877728	K153273	000
07630030877711	K153273	000
07630030877704	K153273	000
07630030877698	K153273	000
07630030877681	K153273	000
07630030877674	K153273	000
07630030877667	K153273	000
07630030877650	K153273	000
07630030877643	K153273	000
07630030877636	K153273	000
07630030877735	K153273	000
07630030877742	K153273	000
07630030877841	K153273	000
07630030877834	K153273	000
07630030877827	K153273	000
07630030877810	K153273	000
07630030877803	K153273	000
07630030877797	K153273	000
07630030877780	K153273	000
07630030877773	K153273	000
07630030877766	K153273	000
07630030877759	K153273	000
07630030877629	K153273	000