← Back to catalogue

TIGER Spine System

FDA UDI

Class II (US FDA UDI)

by Corelink Llc

Identity

Trade Name
TIGER Spine System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
5500 SERIES MONO-AXIAL SCREW - 6.5MM X 45MM FDA UDI
Model / Reference
55465-45 FDA UDI
Description
5500 SERIES MONO-AXIAL SCREW - 6.5MM X 45MM FDA UDI

Identifiers

Catalog Number
55465-45 FDA UDI
Primary DI / UDI-DI
M7255546545 FDA UDI
FDA Product Code
MNH FDA UDI
MNI 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
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

Dimensions & Sizes

Size
Length — 45 Millimeter FDA UDI
Outer Diameter — 6.5 Millimeter FDA UDI

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

TIGER Spine System 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Corelink Llc

Sources (1)

  • FDA UDI f3ece928-dde5-4952-b5d3-4bcceb6defba 36 fields · synced May 31, 2026