M.U.S.T. Anodized Rod
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Straight Rod Ti 5.5 x 300mm - Anodized - Sterile EUDAMEDM.U.S.T. Anodized Rod FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Anodized Rod Ti 5.5x300 FDA UDI
- Model / Reference
- 03.50.802 EUDAMEDFDA UDISpine MUST rod EUDAMED
- Description
- Anodized Rod Ti 5.5x300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030861321 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VIS0064R061XY EUDAMED
- 510(k) Number
- K162061 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDIMNH 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
- 888.3050 FDA UDI888.3060 FDA UDI888.3070 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: Bone-screw internal spinal fixation system rod
M.U.S.T. Anodized Rod 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
K162061 also covers:
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — Medacta International
- M.U.S.T. Anodized Rod — 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 b5455b8e-b791-47cb-ad81-f27fd4c50d5a 34 fields · synced Jun 19, 2026
- EUDAMED 3d46b798-4e51-41be-9d3b-76829777fdd6 61 fields · synced Jun 19, 2026