CoLink

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: CoLink FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: COLINK 2, SPEED DRILL GUIDE, Ø2.0 & Ø2.5, NON-STERILE FDA UDI
Model / Reference: P04 N0311 FDA UDI
Description: COLINK 2, SPEED DRILL GUIDE, Ø2.0 & Ø2.5, NON-STERILE FDA UDI

Identifiers

Catalog Number: P04 N0311 FDA UDI
Primary DI / UDI-DI: 00810021863733 FDA UDI
510(k) Number: K201149 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical drill guide, reusable 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Surgical drill guide, reusable

CoLink by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical drill guide, reusable.

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Truliant — Exactech, Inc. · Class II
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Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I

Cleared under the same submission

K201149 also covers:

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: In2Bones, USA

Sources (1)

FDA UDI 221cc4e1-a309-45ac-a543-aae2a5d76f2b 36 fields · synced May 30, 2026