M.U.S.T. Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for M.u.s.t. Pedicle Screw System.

Pre-market Notification Details

• Device ID: K153664
• 510k Number: K153664
• Device Name: M.U.S.T. Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDACTA INTERNATIONAL STRADA REGINA Castel San Pietro, CH Ch6874
• Contact: Michael G. Loiterman
• Correspondent: Michael G. Loiterman; MEDACTA USA 1556 West Carroll Avenue Chicago, IL 60607
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-21
• Decision Date: 2016-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030805387	K153664	000
07630030846885	K153664	000
07630030846892	K153664	000
07630030846908	K153664	000
07630030846915	K153664	000
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07630030846946	K153664	000
07630030846953	K153664	000
07630030846960	K153664	000
07630030846977	K153664	000
07630030846984	K153664	000
07630030846991	K153664	000
07630030846878	K153664	000
07630030846861	K153664	000
07630030846854	K153664	000
07630030805394	K153664	000
07630030805400	K153664	000
07630030805417	K153664	000
07630030805424	K153664	000
07630030805431	K153664	000
07630030846786	K153664	000
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07630030846809	K153664	000
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07630030847004	K153664	000
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07630030847028	K153664	000
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07630030861215	K153664	000