CorticaLINK MI

FDA UDI

Class I (US FDA UDI)

by Linkspine, Inc.

Identity

Trade Name: CorticaLINK MI FDA UDI
Generic Name: Orthopaedic implantation sleeve, single-use FDA UDI
Device Name: Dilator 3 FDA UDI
Model / Reference: 80-4703 FDA UDI
Description: Dilator 3 FDA UDI

Identifiers

Catalog Number: 80-4703 FDA UDI
Primary DI / UDI-DI: 00817329023234 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic implantation sleeve, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

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: Orthopaedic implantation sleeve, single-use

CorticaLINK MI by Linkspine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FuzeFix Max FT — FUSION ORTHOPEDICS, LLC · Class II
IntraLock — FUSION ORTHOPEDICS, LLC · Class II
My Spine Pedicle Screw Placement Guides — Medacta International · Class II
EASS — FIELD ORTHOPAEDICS PTY LTD · Class II
Exchange Tube — Orthopedic Designs North America, 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 I	Pending data

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Manufacturer

Manufacturer: Linkspine, Inc.

Sources (1)

FDA UDI 645fcc73-151f-4bf7-9956-07c17b40a003 35 fields · synced Jun 1, 2026