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M.U.S.T. Set Screw
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 03.50.200Model Spine MUST setscrew
Identity
- Trade Name
- Set screw (1x) Sterile EUDAMEDM.U.S.T. Set Screw FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- Set screw (1x) Sterile FDA UDI
- Model / Reference
- 03.50.200 EUDAMEDFDA UDISpine MUST setscrew EUDAMED
- Description
- Set screw (1x) Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030834844 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VIS0024R061WC 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 set screw 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spinal bone set screw
M.U.S.T. Set 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 set screw.
- COSY — SIGNUS Medizintechnik GmbH · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- 4CIS APOLLON SPINE SYSTEM — ALPHANOX CO., LTD. · Class II
- Momentum — ULRICH MEDICAL USA, INC. · Class II
- SET SCREW — OsteoCentric Technologies,Inc · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Annex® Adjacent Level System — Spine Wave, Inc. · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · 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
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI e9da93fc-15ee-46d8-9000-0dc4cdf583b4 34 fields · synced Jul 12, 2026
- EUDAMED 621a63b9-1ae5-4053-b74d-62d205ccaf2d 61 fields · synced Jul 12, 2026