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Malibu

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Malibu FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
TSC Uni-Planar Screw 7.0 x 70mm FDA UDI
Model / Reference
70-7070 FDA UDI
Description
TSC Uni-Planar Screw 7.0 x 70mm FDA UDI

Identifiers

Catalog Number
70-7070 FDA UDI
Primary DI / UDI-DI
10889981009793 FDA UDI
510(k) Number
K122571 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

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

K122571 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 c8be8728-93db-48c3-a1d5-351bc8ed0354 38 fields · synced Jun 8, 2026