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LOSPA Surgical Instruments KA.DFM.E001

by Corentec Co., Ltd

LOSPA Surgical Instruments KA.DFM.E001 is a Class I device made by Corentec Co., Ltd, listed in FDA GUDID since 25 Nov 2025 (UDI-DI 08800017299020), 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 Number08800017299020 UDI-DI Date25 Nov 2025ListedStatusListed 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  • Withdrawn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
LOSPA Surgical Instruments
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference
KA.DFM.E001
Primary DI / UDI-DI
08800017299020
FDA product code
LXH
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).

Other devices from Corentec Co., Ltd

See all devices from Corentec Co., Ltd →

Properties

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