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Malibu

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Malibu FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Malibu Polyaxial Reduction Screw,8.0 x 105mm FDA UDI
Model / Reference
13-8005 FDA UDI
Description
Malibu Polyaxial Reduction Screw,8.0 x 105mm FDA UDI

Identifiers

Catalog Number
13-8005 FDA UDI
Primary DI / UDI-DI
10889981002688 FDA UDI
510(k) Number
K051942 FDA UDI
FDA Product Code
KWP FDA UDI
MNI FDA UDI
MNH FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution
Not 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Malibu by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K051942 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI 702d89b8-9b52-4155-822c-3c9be8f43753 38 fields · synced Jun 8, 2026