Identity
- Trade Name
- Malibu™ FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- ROD CONNECTOR, 5.5 x 5.5 FDA UDI
- Model / Reference
- 12-0045 FDA UDI
- Description
- ROD CONNECTOR, 5.5 x 5.5 FDA UDI
Identifiers
- Catalog Number
- 12-0045 FDA UDI
- Primary DI / UDI-DI
- 10889981030001 FDA UDI
- 510(k) Number
- K061342 FDA UDI
- FDA Product Code
- MNH FDA UDINKB FDA UDIMNI FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system connector
Malibu™ by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — 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
K061342 also covers:
- Malibu — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — SeaSpine Orthopedics Corporation
- Malibu™ — 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 0fd86e4a-98b0-4fff-a1e2-990780b2bd3f 37 fields · synced Jun 8, 2026