M.U.S.T. Polyaxial Pedicle Screw
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Pedicle screw 4.5x30mm + Nut (1x) - Sterile EUDAMEDM.U.S.T. Polyaxial Pedicle Screw FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Pedicle screw 4.5x30mm + Nut (1x) - Sterile FDA UDI
- Model / Reference
- 03.50.003 EUDAMEDFDA UDISpine MUST screw (tulip) EUDAMED
- Description
- Pedicle screw 4.5x30mm + Nut (1x) - Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030834066 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VIS0084R061YS EUDAMED
- 510(k) Number
- K121115 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDINKB FDA UDIKWQ FDA UDIKWP FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 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
Yes
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 screw, non-bioabsorbable
M.U.S.T. Polyaxial Pedicle Screw by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
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- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
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- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K121115 also covers:
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — Medacta International
- M.U.S.T. Polyaxial Pedicle Screw — 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 d2d0b741-2bc5-4756-b2f6-af1a15b57795 34 fields · synced Jun 19, 2026
- EUDAMED 1c737b8a-8431-4474-9276-ce1d59f893f2 61 fields · synced Jun 19, 2026