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CoreLink Foundation 3D Stand Alone Screw

FDA UDI

Class II (US FDA UDI)

by Corelink Llc

Identity

Trade Name
CoreLink Foundation 3D Stand Alone Screw FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 25mm FDA UDI
Model / Reference
10355-25 FDA UDI
Description
Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 25mm FDA UDI

Identifiers

Primary DI / UDI-DI
M7251035525 FDA UDI
FDA Product Code
OVD FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

CoreLink Foundation 3D Stand Alone Screw by Corelink Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corelink Llc

Sources (1)

  • FDA UDI 54e22952-e071-4393-a7bf-8eee65818ecf 34 fields · synced Jun 1, 2026