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Optima™ Spinal System SI0230

by CG MedTech Co., Ltd.

Optima™ Spinal System SI0230 is a Class I device made by CG MedTech Co., Ltd., listed in FDA GUDID since 2 Nov 2017 (UDI-DI 08800015951890), 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 Number08800015951890 UDI-DI Date2 Nov 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  • Withdrawn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
Optima™ Spinal System
Generic name
Abdominal/ENT/orthopaedic surgical probe, reusable
Model / reference
SI0230
Primary DI / UDI-DI
08800015951890
FDA product code
LXH
GMDN term
Abdominal/ENT/orthopaedic surgical probe, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Abdominal/ENT/orthopaedic surgical probe, reusable

Similar devices in this category

Other devices filed under Abdominal/ENT/orthopaedic surgical probe, reusable.

Other devices from CG MedTech Co., Ltd.

See all devices from CG MedTech Co., Ltd. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)