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IO-FLEX iO-Tome7.5

by Spinal Elements, Inc.

IO-FLEX iO-Tome7.5 is a Class II device made by Spinal Elements, Inc., listed in FDA GUDID since 12 Jun 2017 (UDI-DI 00840916103866), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840916103866 UDI-DI Date12 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Io-Flex
Generic name
Orthopaedic prosthesis implantation positioning instrument, single-use
Model / reference
iO-Tome7.5
Primary DI / UDI-DI
00840916103866
FDA product code
HAE
GMDN term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device class
Class II
Regulation number
882.4840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, single-use.

Other devices from Spinal Elements, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)