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6550045

by Medtronic Sofamor Danek, Inc.

6550045 is a Class I device made by Medtronic Sofamor Danek, Inc., listed in FDA GUDID since 28 Dec 2024 (UDI-DI 00763000712020), registry data as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000712020 UDI-DI Date28 Dec 2024ListedStatusListed 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  • Withdrawn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

Generic name
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Model / reference
6550045
Primary DI / UDI-DI
00763000712020
FDA product code
KIH
GMDN term
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Device class
Class I
Regulation number
888.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic cement/bone filler dispensing gun

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Other devices filed under Orthopaedic cement/bone filler dispensing gun.

Other devices from Medtronic Sofamor Danek, Inc.

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Properties

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