M.U.S.T. Pedicle Screw System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Combined setscrew Ti h 3.9mm EUDAMEDM.U.S.T. Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- MUST LT - Combined setscrew Ti h 3.9mm FDA UDI
- Model / Reference
- 03.57.903 EUDAMEDFDA UDISpine MUST setscrew EUDAMED
- Description
- MUST LT - Combined setscrew Ti h 3.9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630971278974 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VIS0024R061WC EUDAMED
- 510(k) Number
- K203482 FDA UDI
- FDA Product Code
- KWQ FDA UDINKB FDA UDIKWP FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone set screw FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI888.3050 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Spinal bone set screw
M.U.S.T. Pedicle Screw System by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone set screw.
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Cleared under the same submission
K203482 also covers:
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
- M.U.S.T. Pedicle Screw System — Medacta International
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI d95220e1-63d7-4187-9f8a-e2c667b02990 34 fields · synced Jun 19, 2026
- EUDAMED e47ed88b-daf0-4c7a-b184-b57d0380b64d 61 fields · synced Jun 19, 2026