M.U.S.T PEDICLE SCREW SYSTEM

Appliance, Fixation, Spinal Interlaminal

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: K121115
• 510k Number: K121115
• Device Name: M.U.S.T PEDICLE SCREW SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• 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: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-12
• Decision Date: 2012-07-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030835544	K121115	000
07630030835339	K121115	000
07630030834844	K121115	000
07630030834363	K121115	000
07630030834356	K121115	000
07630030834349	K121115	000
07630030834332	K121115	000
07630030834325	K121115	000
07630030834318	K121115	000
07630030834301	K121115	000
07630030834295	K121115	000
07630030835346	K121115	000
07630030835353	K121115	000
07630030835537	K121115	000
07630030835520	K121115	000
07630030835513	K121115	000
07630030835506	K121115	000
07630030835490	K121115	000
07630030835445	K121115	000
07630030835438	K121115	000
07630030835421	K121115	000
07630030835414	K121115	000
07630030835360	K121115	000
07630030834288	K121115	000
07630030834271	K121115	000
07630030834141	K121115	000
07630030834134	K121115	000
07630030834127	K121115	000
07630030834110	K121115	000
07630030834103	K121115	000
07630030834097	K121115	000
07630030834080	K121115	000
07630030834073	K121115	000
07630030834066	K121115	000
07630030834059	K121115	000
07630030834158	K121115	000
07630030834165	K121115	000
07630030834264	K121115	000
07630030834257	K121115	000
07630030834240	K121115	000
07630030834233	K121115	000
07630030834226	K121115	000
07630030834219	K121115	000
07630030834202	K121115	000
07630030834196	K121115	000
07630030834189	K121115	000
07630030834172	K121115	000
07630030834042	K121115	000
07630030837319	K121115	000
07630030837180	K121115	000
07630030837173	K121115	000
07630030837166	K121115	000
07630030837159	K121115	000
07630030837142	K121115	000
07630030837135	K121115	000
07630030837128	K121115	000
07630030837111	K121115	000
07630030837104	K121115	000
07630030837098	K121115	000
07630030837197	K121115	000
07630030837203	K121115	000
07630030837302	K121115	000
07630030837296	K121115	000
07630030837289	K121115	000
07630030837272	K121115	000
07630030837265	K121115	000
07630030837258	K121115	000
07630030837241	K121115	000
07630030837234	K121115	000
07630030837227	K121115	000
07630030837210	K121115	000
07630030837081	K121115	000
07630030837074	K121115	000
07630030835650	K121115	000
07630030835643	K121115	000
07630030835636	K121115	000
07630030835629	K121115	000
07630030835612	K121115	000
07630030835605	K121115	000
07630030835599	K121115	000
07630030835582	K121115	000
07630030835575	K121115	000
07630030835568	K121115	000
07630030835667	K121115	000
07630030835674	K121115	000
07630030837067	K121115	000
07630030835766	K121115	000
07630030835759	K121115	000
07630030835742	K121115	000
07630030835735	K121115	000
07630030835728	K121115	000
07630030835711	K121115	000
07630030835704	K121115	000
07630030835698	K121115	000
07630030835681	K121115	000
07630030835551	K121115	000