The following data is part of a premarket notification filed by Medacta International with the FDA for M.u.s.t. Extension.
| Device ID | K141044 |
| 510k Number | K141044 |
| Device Name: | M.U.S.T. EXTENSION |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDACTA INTERNATIONAL 1556 W. CARROLL AVENUE Chicago, IL 60607 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 1556 W. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-23 |
| Decision Date | 2014-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030836251 | K141044 | 000 |
| 07630030836138 | K141044 | 000 |
| 07630030836121 | K141044 | 000 |
| 07630030836114 | K141044 | 000 |
| 07630030836107 | K141044 | 000 |
| 07630030836091 | K141044 | 000 |
| 07630030836084 | K141044 | 000 |
| 07630030836077 | K141044 | 000 |
| 07630030836060 | K141044 | 000 |
| 07630030836145 | K141044 | 000 |
| 07630030836152 | K141044 | 000 |
| 07630030836169 | K141044 | 000 |
| 07630030836244 | K141044 | 000 |
| 07630030836237 | K141044 | 000 |
| 07630030836220 | K141044 | 000 |
| 07630030836213 | K141044 | 000 |
| 07630030836206 | K141044 | 000 |
| 07630030836190 | K141044 | 000 |
| 07630030836183 | K141044 | 000 |
| 07630030836176 | K141044 | 000 |
| 07630030836053 | K141044 | 000 |