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CoLink™

FDA UDI

Class II (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
CoLink™ FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
CoLink™ View Screw, Ø3.5 x 20mm,Transverse FDA UDI
Model / Reference
V35 ST420 FDA UDI
Description
CoLink™ View Screw, Ø3.5 x 20mm,Transverse FDA UDI

Identifiers

Catalog Number
V35 ST420 FDA UDI
Primary DI / UDI-DI
00817906021189 FDA UDI
510(k) Number
K163293 FDA UDI
K172300 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K163293 also covers:

K172300 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2Bones, USA

Sources (1)

  • FDA UDI 28627446-0124-4531-aef7-e8499aa32151 38 fields · synced Jun 6, 2026