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Malibu™

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Malibu™ FDA UDI
Generic Name
Orthopaedic bone cerclage wire FDA UDI
Device Name
ESS SUBLAMINAR WIRE, 1.2 mm FDA UDI
Model / Reference
15-0012 FDA UDI
Description
ESS SUBLAMINAR WIRE, 1.2 mm FDA UDI

Identifiers

Catalog Number
15-0012 FDA UDI
Primary DI / UDI-DI
10889981029883 FDA UDI
510(k) Number
K061342 FDA UDI
FDA Product Code
NKB FDA UDI
KWP FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Orthopaedic bone cerclage wire FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone cerclage wire

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

Similar devices

Also classified as Orthopaedic bone cerclage wire.

Cleared under the same submission

K061342 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 761610fa-5609-4dc7-a185-fb9bbc3c6615 37 fields · synced Jun 8, 2026