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945CNCPS101

by Medtronic Sofamor Danek, Inc.

945CNCPS101 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K050798 on 15 Aug 2005 and listed in FDA GUDID since 16 Apr 2016 (UDI-DI 00643169071711), 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) K050798

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 Number00643169071711 UDI-DI Date16 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050798 Date15 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050798 decided 15 Aug 2005 Active
  • FDA GUDID UDI-DI 00643169071711 listed 16 Apr 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050798
  2. Listed FDA GUDID 00643169071711

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  • Withdrawn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
945CNCPS101
Primary DI / UDI-DI
00643169071711
510(k) Number
FDA product code
GWE, GWF, GWS, GWQ, GWJ
GMDN term
Nerve-locating system
Device class
Class II
Regulation number
882.1890, 882.1870, 882.1420, 882.1400, 882.1900
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Nerve-locating system

Cleared under the same submission (K050798)

and 8 more cleared under K050798

Similar devices

Other devices filed under FDA product code GWE (STIMULATOR, PHOTIC, EVOKED RESPONSE).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

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