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Orthex R635-04-SQ

by Orthopediatrics Corp.

Orthex R635-04-SQ is a Class II device made by Orthopediatrics Corp., listed in FDA GUDID since 28 Feb 2020 (UDI-DI 00841132180471), 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 Number00841132180471 UDI-DI Date28 Feb 2020ListedStatusListed 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  • Withdrawn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
Orthex
Generic name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
R635-04-SQ
Primary DI / UDI-DI
00841132180471
FDA product code
KTT
GMDN term
External orthopaedic fixation system noninvasive component, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: External orthopaedic fixation system noninvasive component, single-use

Similar devices

Other devices filed under FDA product code KTT (APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT).

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)