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Valeo Spacer System

by Amedica Corp.

510(k) K091278

Valeo Spacer System is a Class II device made by Amedica Corp., cleared under FDA 510(k) K091278 on 28 Jan 2010, 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 NumberK091278 Date28 Jan 2010ClearedStatusActive

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  • Withdrawn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

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

Cited by

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

Devices cleared under K091278

203 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 K091278
UDI-DISize and differences
GENERIC Surgical Instruments 91.001.1008
CTL Medical Corporation
91.001.100800841732141179
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3002
CTL Medical Corporation
91.001.300200841732111646
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3004
CTL Medical Corporation
91.001.300400841732159648
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3008
CTL Medical Corporation
91.001.300800841732162297
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3010
CTL Medical Corporation
91.001.301000841732162303
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3014
CTL Medical Corporation
91.001.301400841732162341
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3016
CTL Medical Corporation
91.001.301600841732162365
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3115
CTL Medical Corporation
91.001.311500841732162457
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3209
CTL Medical Corporation
91.001.320900841732162495
Single use: no
On the market
GENERIC Surgical Instruments 91.001.3213
CTL Medical Corporation
91.001.321300841732162532
Single use: no
On the market
GENERIC Surgical Instruments 91.002.5004
CTL Medical Corporation
91.002.500400841732163515
Single use: no
On the market
VALEO 11.007.1150
CTL Medical Corporation
11.007.115000841732159167
Single use: yes
No longer on the market
VALEO C Spacer System 11.002.1608
CTL Medical Corporation
11.002.160800841732140851
Single use: yes
On the market
VALEO C Spacer System 11.002.1609
CTL Medical Corporation
11.002.160900841732155817
Single use: yes
On the market
VALEO C Spacer System 11.009.1006
CTL Medical Corporation
11.009.100600841732154513
Single use: yes
On the market
VALEO C Spacer System 11.009.1009
CTL Medical Corporation
11.009.100900841732154544
Single use: yes
On the market
VALEO C Spacer System 11.009.1011
CTL Medical Corporation
11.009.101100841732154568
Single use: yes
On the market
VALEO C Spacer System 11.009.1012
CTL Medical Corporation
11.009.101200841732154575
Single use: yes
On the market
VALEO C Spacer System 11.009.2008
CTL Medical Corporation
11.009.200800841732154681
Single use: yes
On the market
VALEO C Spacer System 11.009.2010
CTL Medical Corporation
11.009.201000841732154704
Single use: yes
On the market
VALEO C Spacer System 11.009.2011
CTL Medical Corporation
11.009.201100841732154711
Single use: yes
On the market
VALEO C Spacer System 11.009.2606
CTL Medical Corporation
11.009.260600841732159990
Single use: yes
On the market
VALEO C Spacer System 11.009.2608
CTL Medical Corporation
11.009.260800841732145290
Single use: yes
On the market
VALEO C Spacer System 11.009.2611
CTL Medical Corporation
11.009.261100841732145306
Single use: yes
On the market
VALEO C Spacer System 91.002.2110
CTL Medical Corporation
91.002.211000841732162853
Single use: no
On the market
VALEO C Spacer System 91.002.2112
CTL Medical Corporation
91.002.211200841732162877
Single use: no
On the market
VALEO C Spacer System 91.002.2205
CTL Medical Corporation
91.002.220500841732162884
Single use: no
On the market
VALEO C Spacer System 91.002.2307
CTL Medical Corporation
91.002.230700841732162983
Single use: no
On the market
VALEO C Spacer System 91.002.2312
CTL Medical Corporation
91.002.231200841732163034
Single use: no
On the market
VALEO C Spacer System 91.002.2405
CTL Medical Corporation
91.002.240500841732163041
Single use: no
On the market
VALEO C Spacer System 91.002.2406
CTL Medical Corporation
91.002.240600841732163058
Single use: no
On the market
VALEO C Spacer System 91.002.2408
CTL Medical Corporation
91.002.240800841732163072
Single use: no
On the market
VALEO C Spacer System 91.002.3207
CTL Medical Corporation
91.002.320700841732163225
Single use: no
On the market
VALEO C Spacer System 91.002.3212
CTL Medical Corporation
91.002.321200841732163270
Single use: no
On the market
VALEO C Spacer System 91.002.3308
CTL Medical Corporation
91.002.330800841732163317
Single use: no
On the market
VALEO C Spacer System 91.002.3410
CTL Medical Corporation
91.002.341000841732163416
Single use: no
On the market
VALEO C Spacer System 91.002.3411
CTL Medical Corporation
91.002.341100841732163423
Single use: no
On the market
VALEO C Spacer System 91.002.4006
CTL Medical Corporation
91.002.400600841732163478
Single use: no
On the market
VALEO C Spacer System 91.002.4106
CTL Medical Corporation
91.002.410600841732163492
Single use: no
On the market
VALEO PL OL Interbody Fusion System 11.013.1607
CTL Medical Corporation
11.013.160700841732159129
Single use: yes
On the market
VALEO PL OL Interbody Fusion System 11.013.1608
CTL Medical Corporation
11.013.160800841732159112
Single use: yes
On the market
VALEO TL Spacer System 91.001.3507
CTL Medical Corporation
91.001.350700841732162570
Single use: no
On the market
VALEO TL Spacer System 91.001.3513
CTL Medical Corporation
91.001.351300841732162631
Single use: no
On the market
VALEO TL Spacer System 91.001.3514
CTL Medical Corporation
91.001.351400841732162648
Single use: no
On the market
VALEO TL Spacer System 91.001.3517
CTL Medical Corporation
91.001.351700841732162679
Single use: no
On the market
VALEO TL Spacer System 91.001.4039
CTL Medical Corporation
91.001.403900841732157279
Single use: no
On the market
VALEO VBR 11.009.1615
CTL Medical Corporation
11.009.161500841732145252
Single use: yes
On the market
VALEO VBR 11.009.1617
CTL Medical Corporation
11.009.161700841732145269
Single use: yes
On the market
VALEO VBR 11.009.1627
CTL Medical Corporation
11.009.162700841732145283
Single use: yes
On the market
VALEO VBR 91.009.5652
CTL Medical Corporation
91.009.565200841732128248
Single use: no
On the market

Similar devices

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