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8657018

by Medtronic Sofamor Danek, Inc.

8657018 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K142559 on 9 Jun 2015 and listed in FDA GUDID since 25 Jun 2016 (UDI-DI 00643169484948), 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) K142559

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 Number00643169484948 UDI-DI Date25 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142559 Date9 Jun 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142559 decided 9 Jun 2015 Active
  • FDA GUDID UDI-DI 00643169484948 listed 25 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142559
  2. Listed FDA GUDID 00643169484948

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Instrument tray, reusable
Model / reference
8657018
Primary DI / UDI-DI
00643169484948
510(k) Number
FDA product code
MAX
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K142559)

and 8 more cleared under K142559

Similar devices in this category

Other devices filed under Instrument tray, reusable.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

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