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TIGER Spine OCT System

FDA UDI

Class II (US FDA UDI)

by Corelink Llc

Identity

Trade Name
TIGER Spine OCT System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
3500 SERIES OCCIPITAL ROD - 3.5MM, 120 DEGREES FDA UDI
Model / Reference
R3530-120 FDA UDI
Description
3500 SERIES OCCIPITAL ROD - 3.5MM, 120 DEGREES FDA UDI

Identifiers

Catalog Number
R3530-120 FDA UDI
Primary DI / UDI-DI
M725R3530120 FDA UDI
FDA Product Code
KWP FDA UDI
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
888.3050 FDA UDI
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
Angle — 120 degree FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI

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

TIGER Spine OCT 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

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Manufacturer

Manufacturer
Corelink Llc

Sources (1)

  • FDA UDI 0ef106f1-2f88-4641-8e68-2dbda9c0e498 36 fields · synced May 31, 2026