M.U.S.T. Rods
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Enh. Bent Rod CoCr R100 5.5x120mm - Sterile EUDAMEDM.U.S.T. Rods FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Enh. Bent Rod CoCr R100 5.5x120mm - Sterile FDA UDI
- Model / Reference
- 03.52.570 EUDAMEDFDA UDISpine MUST rod EUDAMED
- Description
- Enh. Bent Rod CoCr R100 5.5x120mm - Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030860027 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VIS0064R061XY EUDAMED
- 510(k) Number
- K141988 FDA UDI
- FDA Product Code
- MNH FDA UDINKB FDA UDIKWP FDA UDIKWQ FDA UDIMNI FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 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: Bone-screw internal spinal fixation system rod
M.U.S.T. Rods by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K141988 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 df38d4e5-291c-40d1-88e9-778ad59909ec 34 fields · synced Jul 20, 2026
- EUDAMED 8404a18f-61f0-42b0-ac7f-754df299e8ea 61 fields · synced Jul 20, 2026