M.U.S.T. EXTENSION

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. Extension.

Pre-market Notification Details

• Device ID: K132878
• 510k Number: K132878
• Device Name: M.U.S.T. EXTENSION
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Contact: Adam Gross
• Correspondent: Adam Gross; MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-13
• Decision Date: 2013-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030834943	K132878	000
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