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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 FDA UDI
Device Name
5500 Series Straight Rod - With Line - 5.5mm X 150mm FDA UDI
Model / Reference
R5511-150 FDA UDI
Description
5500 Series Straight Rod - With Line - 5.5mm X 150mm FDA UDI

Identifiers

Primary DI / UDI-DI
M725R55111500 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 150.0 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corelink Llc

Sources (1)

  • FDA UDI bd4db2dd-7e0b-4746-a564-75cfa18a5188 35 fields · synced May 30, 2026