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VertebraLINK

FDA UDI

Class I (US FDA UDI)

by Linkspine, Inc.

Identity

Trade Name
VertebraLINK FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
VertebraLINK Insertion Tray FDA UDI
Model / Reference
84-0911 FDA UDI
Description
VertebraLINK Insertion Tray FDA UDI

Identifiers

Catalog Number
84-0911 FDA UDI
Primary DI / UDI-DI
00817329025290 FDA UDI
FDA Product Code
LRP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

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

VertebraLINK by Linkspine, Inc. — Class I — 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
Linkspine, Inc.

Sources (1)

  • FDA UDI 7c3faf73-3f06-41eb-a789-dd55d8fe7a91 35 fields · synced May 30, 2026