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945PSP1001

by Medtronic Sofamor Danek, Inc.

945PSP1001 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K061113 on 23 May 2006 and listed in FDA GUDID since 1 Jul 2016 (UDI-DI 20613994327806), active as of 23 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 23 Oct 2026

Documents

510(k) K061113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20613994327806 UDI-DI Date1 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061113 Date23 May 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061113 decided 23 May 2006 Active
  • FDA GUDID UDI-DI 20613994327806 listed 1 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061113
  2. Listed FDA GUDID 20613994327806

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Nerve-locating system
Model / reference
945PSP1001
Primary DI / UDI-DI
20613994327806
510(k) Number
FDA product code
IKN, GWF
GMDN term
Nerve-locating system
Device class
Class II
Regulation number
890.1375, 882.1870
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Nerve-locating system

Cleared under the same submission (K061113)

and 1 more cleared under K061113

Similar devices

Other devices filed under FDA product code IKN (Electromyograph, diagnostic).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

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