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ELEVATE™ Spinal System 8657007

by Medtronic Sofamor Danek, Inc.

ELEVATE™ Spinal System 8657007 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 30 Sep 2015 (UDI-DI 00643169432239), 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 Number00643169432239 UDI-DI Date30 Sep 2015ListedStatusListed 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 00643169432239 listed 30 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142559
  2. Listed FDA GUDID 00643169432239

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ELEVATE™ Spinal System
Generic name
Spinal implant trial
Model / reference
8657007
Primary DI / UDI-DI
00643169432239
510(k) Number
FDA product code
MAX
GMDN term
Spinal implant trial
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal implant trial

Cleared under the same submission (K142559)

and 8 more cleared under K142559

Similar devices

Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).

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)