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CorticaLINK

FDA UDI

Class II (US FDA UDI)

by Linkspine, Inc.

Identity

Trade Name
CorticaLINK FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Cortical Screw: 4.5mm X 45mm FDA UDI
Model / Reference
80-4006/4545 FDA UDI
Description
Cortical Screw: 4.5mm X 45mm FDA UDI

Identifiers

Catalog Number
80-4006/4545 FDA UDI
Primary DI / UDI-DI
00817329020219 FDA UDI
510(k) Number
K160722 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 45 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI

CorticaLINK by Linkspine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Linkspine, Inc.

Sources (1)

  • FDA UDI fa299619-c51d-4969-824d-3831ceb5128b 38 fields · synced Jun 1, 2026