Golden Isles Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Intelivation, LLC

Identity

Trade Name: Golden Isles Pedicle Screw System FDA UDI
Generic Name: Bone distraction forceps FDA UDI
Device Name: Parallel Compressor, Wide FDA UDI
Model / Reference: C50-6000-007 FDA UDI
Description: Parallel Compressor, Wide FDA UDI

Identifiers

Primary DI / UDI-DI: G079C5060000070 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Bone distraction forceps FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone distraction forceps

Golden Isles Pedicle Screw System by Intelivation, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone distraction forceps.

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BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
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KMEDIC — TELEFLEX INCORPORATED · Class I
Invictus — ALPHATEC SPINE, INC. · Class I

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: Intelivation, LLC

Sources (1)

FDA UDI 727a8232-b4c8-4cb9-b950-acf93b623e12 34 fields · synced May 30, 2026