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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-screw internal spinal fixation system sterilization container/implant set FDA UDI
Device Name
Dual Headbody, Modular, Plolyaxial , Reduction FDA UDI
Model / Reference
C25-2800-002 FDA UDI
Description
Dual Headbody, Modular, Plolyaxial , Reduction FDA UDI

Identifiers

Primary DI / UDI-DI
G079C2528000020 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system sterilization container/implant set 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

No

FDA UDI

Single Use

Yes

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

Category: Bone-screw internal spinal fixation system sterilization container/implant set

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

Similar devices

Also classified as Bone-screw internal spinal fixation system sterilization container/implant set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intelivation, LLC

Sources (1)

  • FDA UDI a2aa20b7-43ba-4c97-ab32-1d682299f256 33 fields · synced Jun 1, 2026