M.U.S.T. MINI Posterior Cervical Screws System

Orthosis, Cervical Pedicle Screw Spinal Fixation

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Mini Posterior Cervical Screws System.

Pre-market Notification Details

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• Device ID: K190631
• 510k Number: K190631
• Device Name: M.U.S.T. MINI Posterior Cervical Screws System
• Classification: Orthosis, Cervical Pedicle Screw Spinal Fixation
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: NKG
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-12
• Decision Date: 2019-04-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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07630040733731	K190631	000
07630040733724	K190631	000
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