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907-430

by Medtronic Sofamor Danek, Inc.

907-430 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K040422 on 19 Mar 2004 and listed in FDA GUDID since 5 Aug 2015 (UDI-DI 00681490499866), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K040422

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00681490499866 UDI-DI Date5 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK040422 Date19 Mar 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040422 decided 19 Mar 2004 Active
  • FDA GUDID UDI-DI 00681490499866 listed 5 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040422
  2. Listed FDA GUDID 00681490499866

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / reference
907-430
Primary DI / UDI-DI
00681490499866
510(k) Number
FDA product code
MQP
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Orthopaedic inorganic implant inserter/extractor, reusable.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)