M.U.S.T. Rod-to-Rod Connector
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- In line connector Open 6.35 EUDAMEDM.U.S.T. Rod-to-Rod Connector FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- In Line Connector Open 6.35 FDA UDI
- Model / Reference
- 03.56.206 EUDAMEDFDA UDISpine MUST rod to rod connector EUDAMED
- Description
- In Line Connector Open 6.35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030861529 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VIS0014R061VX EUDAMED
- 510(k) Number
- K162061 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDIMNH FDA UDIMNI FDA UDI
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system connector 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
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 connector
M.U.S.T. Rod-to-Rod Connector 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 connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · 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 b55dec98-4846-49fa-ba0b-362d8a3bf3ec 34 fields · synced Jun 18, 2026
- EUDAMED 16417e91-e415-4935-8968-1829e937c65f 61 fields · synced Jun 18, 2026