CoLink

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: CoLink FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: CoLink Cfx PERIMETER PLATE, LG, LEFT, TRIAL FDA UDI
Model / Reference: P08 N1205 FDA UDI
Description: CoLink Cfx PERIMETER PLATE, LG, LEFT, TRIAL FDA UDI

Identifiers

Catalog Number: P08 N1205 FDA UDI
Primary DI / UDI-DI: 00810021862392 FDA UDI
510(k) Number: K200762 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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 Safe FDA UDI

Category: Surgical implant template, reusable

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

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VFT — Ldr Spine USA · Class II
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I

Cleared under the same submission

K200762 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 4caa1e84-8000-4ef2-b8d0-4f7381c975dd 36 fields · synced May 30, 2026