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Inion GTR™

FDA UDI

Class II (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name
Inion GTR™ FDA UDI
Generic Name
Spinal bone screw, bioabsorbable FDA UDI
Device Name
Tacks, drill bit and tack appl. FDA UDI
Model / Reference
1 FDA UDI
Description
Tacks, drill bit and tack appl. FDA UDI

Identifiers

Catalog Number
TCK-2011 FDA UDI
Primary DI / UDI-DI
M224TCK20119 FDA UDI
510(k) Number
K033074 FDA UDI
FDA Product Code
NPK FDA UDI
GMDN Term
Spinal bone screw, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3930 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spinal bone screw, bioabsorbable

Inion GTR™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, bioabsorbable.

Cleared under the same submission

K033074 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inion , Ltd.

Sources (1)

  • FDA UDI 49e73fa2-6e0e-485d-b6ac-e33214f79f37 36 fields · synced May 29, 2026