MIS Golden Isles Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Intelivation, LLC

Identity

Trade Name: MIS Golden Isles Pedicle Screw System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: MIS Provisional Locking Cap Driver FDA UDI
Model / Reference: C50-8000-003 FDA UDI
Description: MIS Provisional Locking Cap Driver FDA UDI

Identifiers

Primary DI / UDI-DI: G079C5080000030 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Surgical screwdriver, reusable 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: Surgical screwdriver, reusable

MIS 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 Surgical screwdriver, reusable.

Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
PERLA ® TL — Spineart · Class II
USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Intelivation, LLC

Sources (1)

FDA UDI 88ab5ded-498a-4dc5-9306-b7f3d1f19dee 34 fields · synced Jun 8, 2026