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Inion S-2™

FDA UDI

Class II (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name
Inion S-2™ FDA UDI
Generic Name
Spinal fixation plate, bioabsorbable FDA UDI
Device Name
Plate, 40 x 28 x 3.2 mm FDA UDI
Model / Reference
1 FDA UDI
Description
Plate, 40 x 28 x 3.2 mm FDA UDI

Identifiers

Catalog Number
SPN-5402 FDA UDI
Primary DI / UDI-DI
06438408006968 FDA UDI
510(k) Number
K071810 FDA UDI
FDA Product Code
OJB FDA UDI
GMDN Term
Spinal fixation plate, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 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 fixation plate, bioabsorbable

Inion S-2™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, bioabsorbable.

Cleared under the same submission

K071810 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 e8d01c92-6e0e-421a-95ae-086af0db21bb 35 fields · synced May 31, 2026