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ELEVATE Spinal System

by Medtronic Sofamor Danek USA, Inc.

510(k) K142559

ELEVATE Spinal System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K142559 on 9 Jun 2015, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142559 Date9 Jun 2015ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K142559

39 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K142559
UDI-DISize and differences
8657017
MEDTRONIC SOFAMOR DANEK, INC.
865701700643169484931
Single use: no
On the market
8657018
MEDTRONIC SOFAMOR DANEK, INC.
865701800643169484948
Single use: no
On the market
ELEVATE™ Spinal System 7770723
MEDTRONIC SOFAMOR DANEK, INC.
777072300643169430433
Width 10.0 mm; Height 7.0 mm; Length 23.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770728
MEDTRONIC SOFAMOR DANEK, INC.
777072800643169430655
Height 7.0 mm; Length 28.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770732
MEDTRONIC SOFAMOR DANEK, INC.
777073200643169430723
Length 32.0 mm; Height 7.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770823
MEDTRONIC SOFAMOR DANEK, INC.
777082300643169430440
Height 8.0 mm; Length 23.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770828
MEDTRONIC SOFAMOR DANEK, INC.
777082800643169430648
Width 10.0 mm; Length 28.0 mm; Height 8.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770832
MEDTRONIC SOFAMOR DANEK, INC.
777083200643169430730
Width 10.0 mm; Length 32.0 mm; Height 8.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770923
MEDTRONIC SOFAMOR DANEK, INC.
777092300643169430686
Length 23.0 mm; Height 9.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770928
MEDTRONIC SOFAMOR DANEK, INC.
777092800643169430693
Length 28.0 mm; Height 9.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7770932
MEDTRONIC SOFAMOR DANEK, INC.
777093200643169430747
Height 9.0 mm; Length 32.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7771023
MEDTRONIC SOFAMOR DANEK, INC.
777102300643169430679
Width 10.0 mm; Height 10.0 mm; Length 23.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7771028
MEDTRONIC SOFAMOR DANEK, INC.
777102800643169430709
Length 28.0 mm; Width 10.0 mm; Height 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7771032
MEDTRONIC SOFAMOR DANEK, INC.
777103200643169430754
Length 32.0 mm; Height 10.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7771123
MEDTRONIC SOFAMOR DANEK, INC.
777112300643169430662
Height 11.0 mm; Width 10.0 mm; Length 23.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7771128
MEDTRONIC SOFAMOR DANEK, INC.
777112800643169430716
Length 28.0 mm; Height 11.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 7771132
MEDTRONIC SOFAMOR DANEK, INC.
777113200643169430761
Length 32.0 mm; Width 10.0 mm; Height 11.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8657001
MEDTRONIC SOFAMOR DANEK, INC.
865700100643169432178
Single use: no
On the market
ELEVATE™ Spinal System 8657001
MEDTRONIC SOFAMOR DANEK, INC.
865700100763000880255
Single use: no
On the market
ELEVATE™ Spinal System 8657002
MEDTRONIC SOFAMOR DANEK, INC.
865700200763000880262
Single use: no
On the market
ELEVATE™ Spinal System 8657002
MEDTRONIC SOFAMOR DANEK, INC.
865700200643169432185
Single use: no
On the market
ELEVATE™ Spinal System 8657003
MEDTRONIC SOFAMOR DANEK, INC.
865700300643169432192
Single use: no
On the market
ELEVATE™ Spinal System 8657003
MEDTRONIC SOFAMOR DANEK, INC.
865700300763000880279
Single use: no
On the market
ELEVATE™ Spinal System 8657005
MEDTRONIC SOFAMOR DANEK, INC.
865700500643169432215
Single use: no
On the market
ELEVATE™ Spinal System 8657006
MEDTRONIC SOFAMOR DANEK, INC.
865700600643169432222
Single use: no
On the market
ELEVATE™ Spinal System 8657007
MEDTRONIC SOFAMOR DANEK, INC.
865700700643169432239
Single use: no
On the market
ELEVATE™ Spinal System 8657008
MEDTRONIC SOFAMOR DANEK, INC.
865700800643169432246
Single use: no
On the market
ELEVATE™ Spinal System 8880823
MEDTRONIC SOFAMOR DANEK, INC.
888082300643169430778
Height 8.0 mm; Length 23.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8880828
MEDTRONIC SOFAMOR DANEK, INC.
888082800643169430815
Height 8.0 mm; Width 10.0 mm; Length 28.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8880832
MEDTRONIC SOFAMOR DANEK, INC.
888083200643169430853
Length 32.0 mm; Width 10.0 mm; Height 8.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8880923
MEDTRONIC SOFAMOR DANEK, INC.
888092300643169430785
Width 10.0 mm; Height 9.0 mm; Length 23.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8880928
MEDTRONIC SOFAMOR DANEK, INC.
888092800643169430822
Width 10.0 mm; Height 9.0 mm; Length 28.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8880932
MEDTRONIC SOFAMOR DANEK, INC.
888093200643169430860
Height 9.0 mm; Width 10.0 mm; Length 32.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8881023
MEDTRONIC SOFAMOR DANEK, INC.
888102300643169430792
Width 10.0 mm; Height 10.0 mm; Length 23.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8881028
MEDTRONIC SOFAMOR DANEK, INC.
888102800643169430839
Width 10.0 mm; Height 10.0 mm; Length 28.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8881032
MEDTRONIC SOFAMOR DANEK, INC.
888103200643169430877
Length 32.0 mm; Width 10.0 mm; Height 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8881123
MEDTRONIC SOFAMOR DANEK, INC.
888112300643169430808
Height 11.0 mm; Length 23.0 mm; Width 10.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8881128
MEDTRONIC SOFAMOR DANEK, INC.
888112800643169430846
Width 10.0 mm; Length 28.0 mm; Height 11.0 mm
Single use: yes
On the market
ELEVATE™ Spinal System 8881132
MEDTRONIC SOFAMOR DANEK, INC.
888113200643169430884
Height 32.0 mm; Length 10.0 mm; Height 11.0 mm
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

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