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Io-Flex

FDA UDI

Class II (US FDA UDI)

by Spinal Elements, Inc.

Identity

Trade Name
IO-FLEX FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
IO-Flex Microblade Shaver IO-Tome Device 7.5mm FDA UDI
Model / Reference
iO-Tome7.5 FDA UDI
Description
IO-Flex Microblade Shaver IO-Tome Device 7.5mm FDA UDI

Identifiers

Primary DI / UDI-DI
00840916103866 FDA UDI
FDA Product Code
HAE FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4840 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Io-Flex by Spinal Elements, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinal Elements, Inc.

Sources (1)

  • FDA UDI 15201d66-9c10-4330-ab3c-16561fcae6b4 33 fields · synced Jun 6, 2026