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Inion S-1™

FDA UDI

Class II (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name
Inion S-1™ FDA UDI
Generic Name
Spinal bone screw, bioabsorbable FDA UDI
Device Name
4.5 x 14 mm screw (4 x) FDA UDI
Model / Reference
1 FDA UDI
Description
4.5 x 14 mm screw (4 x) FDA UDI

Identifiers

Catalog Number
SPN-5201 FDA UDI
Primary DI / UDI-DI
M224SPN52019 FDA UDI
510(k) Number
K051821 FDA UDI
FDA Product Code
OJB FDA UDI
GMDN Term
Spinal bone screw, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
Not 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

The Inion S-1 is a small, threaded implantable rod used for internal spinal fixation in surgical procedures such as spinal discectomy and fusion. It features a screw head and drive designed to secure a stabilization device, typically made of degradable polymers, to the spine.

Cleared under the same submission

K051821 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 61dac19e-80b7-4012-a1b9-a26a7d924ef9 36 fields · synced Jun 28, 2026