Identity
- Trade Name
- M.U.S.T. Hooks FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system FDA UDI
- Device Name
- Pedicle Hook M + Nut (1x) - Sterile FDA UDI
- Model / Reference
- 03.50.622 FDA UDI
- Description
- Pedicle Hook M + Nut (1x) - Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030836152 FDA UDI
- 510(k) Number
- K141044 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDINKB FDA UDIMNH FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3060 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Bone-screw internal spinal fixation system
M.U.S.T. Hooks by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system.
- TIGER Spine System — CORELINK LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
- TIGER Spine System — CORELINK LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
- TIGER Spine System — CORELINK LLC · Class II
Cleared under the same submission
K141044 also covers:
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
- M.U.S.T. Hooks — Medacta International
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI 747c9998-282f-4bf0-9088-f3731547e61c 34 fields · synced May 29, 2026