CoLink

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: CoLink FDA UDI
Generic Name: Orthopaedic bur, reusable FDA UDI
Device Name: CoLink Vallux Olive Wire - Ø.045, Long, Non-Sterile FDA UDI
Model / Reference: P09 N0051 FDA UDI
Description: CoLink Vallux Olive Wire - Ø.045, Long, Non-Sterile FDA UDI

Identifiers

Catalog Number: P09 N0051 FDA UDI
Primary DI / UDI-DI: 00810021866581 FDA UDI
510(k) Number: K212487 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Orthopaedic bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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: Orthopaedic bur, reusable

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

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Also classified as Orthopaedic bur, reusable.

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KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I

Cleared under the same submission

K212487 also covers:

CoLink Vallux — In2Bones, USA

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 4cf4abc7-42ea-4240-a040-5410ce23a2fb 36 fields · synced May 29, 2026