Identity
- Trade Name
- Malibu FDA UDI
- Generic Name
- Vertebral body prosthesis, non-sterile FDA UDI
- Device Name
- Malibu Deformity Hook Implant. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt. FDA UDI
- Model / Reference
- MLBDHIMP FDA UDI
- Description
- Malibu Deformity Hook Implant. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt. FDA UDI
Identifiers
- Catalog Number
- MLBDHIMP FDA UDI
- Primary DI / UDI-DI
- 10889981028121 FDA UDI
- 510(k) Number
- K052170 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vertebral body prosthesis, non-sterile
Malibu by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052170 also covers:
- Cambria™ — SeaSpine Orthopedics Corporation
- Cambria™ — SeaSpine Orthopedics Corporation
- Cambria™ — SeaSpine Orthopedics Corporation
- NewPort™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Hollywood™ — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Pacifica — SeaSpine Orthopedics Corporation
- SeaSpine Spacer System - Pacifica™ — SeaSpine Orthopedics Corporation
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 8ac08ad3-cfbb-4c36-858f-122fd5cb7608 36 fields · synced Jun 8, 2026