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Abacus Tm Spacer System

by Spine Wave, Inc.

510(k) K140007

Abacus Tm Spacer System is a Class II device made by Spine Wave, Inc., cleared under FDA 510(k) K140007 on 7 Apr 2014, 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 NumberK140007 Date7 Apr 2014ClearedStatusActive

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  • Withdrawn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 K140007

72 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 K140007
UDI-DISize and differences
Abacus® Spacer System 11-9010
Spine Wave, Inc.
11-9010 / 11-901010840642101164
Length 40 mm; Width 18 mm; Height 8 mm
On the market
Abacus® Spacer System 11-9011
Spine Wave, Inc.
11-9011 / 11-901110840642101171
Height 10 mm; Width 18 mm; Length 40 mm
On the market
Abacus® Spacer System 11-9013
Spine Wave, Inc.
11-9013 / 11-901310840642101195
Length 40 mm; Width 18 mm; Height 14 mm
On the market
Abacus® Spacer System 11-9017
Spine Wave, Inc.
11-9017 / 11-901710840642101485
Height 12 mm; Width 18 mm; Length 45 mm
On the market
Abacus® Spacer System 11-9018
Spine Wave, Inc.
11-9018 / 11-901810840642101492
Length 45 mm; Width 18 mm; Height 14 mm
On the market
Abacus® Spacer System 11-9020
Spine Wave, Inc.
11-9020 / 11-902010840642101768
Height 8 mm; Width 18 mm; Length 50 mm
On the market
Abacus® Spacer System 11-9021
Spine Wave, Inc.
11-9021 / 11-902110840642101775
Length 50 mm; Width 18 mm; Height 10 mm
On the market
Abacus® Spacer System 11-9022
Spine Wave, Inc.
11-9022 / 11-902210840642101782
Height 12 mm; Width 18 mm; Length 50 mm
On the market
Abacus® Spacer System 11-9025
Spine Wave, Inc.
11-9025 / 11-902510840642102062
Height 8 mm; Width 18 mm; Length 55 mm
On the market
Abacus® Spacer System 11-9026
Spine Wave, Inc.
11-9026 / 11-902610840642102079
Width 18 mm; Length 55 mm; Height 10 mm
On the market
Abacus® Spacer System 11-9028
Spine Wave, Inc.
11-9028 / 11-902810840642102093
Width 18 mm; Length 55 mm; Height 14 mm
On the market
Abacus® Spacer System 11-9031
Spine Wave, Inc.
11-9031 / 11-903110840642103922
Width 18 mm; Length 60 mm; Height 10 mm
On the market
Abacus® Spacer System 11-9032
Spine Wave, Inc.
11-9032 / 11-903210840642103939
Length 60 mm; Height 12 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9036
Spine Wave, Inc.
11-9036 / 11-903610840642101324
Width 18 mm; Height 10 mm; Length 40 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9037
Spine Wave, Inc.
11-9037 / 11-903710840642101331
Length 40 mm; Angle 10 deg; Height 12 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9041
Spine Wave, Inc.
11-9041 / 11-904110840642101621
Width 18 mm; Height 10 mm; Angle 10 deg; Length 45 mm
On the market
Abacus® Spacer System 11-9042
Spine Wave, Inc.
11-9042 / 11-904210840642101638
Length 45 mm; Angle 10 deg; Height 12 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9043
Spine Wave, Inc.
11-9043 / 11-904310840642101645
Width 18 mm; Height 14 mm; Angle 10 deg; Length 45 mm
On the market
Abacus® Spacer System 11-9045
Spine Wave, Inc.
11-9045 / 11-904510840642101911
Length 50 mm; Angle 10 deg; Height 8 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9046
Spine Wave, Inc.
11-9046 / 11-904610840642101928
Width 18 mm; Height 10 mm; Angle 10 deg; Length 50 mm
On the market
Abacus® Spacer System 11-9048
Spine Wave, Inc.
11-9048 / 11-904810840642101942
Width 18 mm; Height 14 mm; Angle 10 deg; Length 50 mm
On the market
Abacus® Spacer System 11-9051
Spine Wave, Inc.
11-9051 / 11-905110840642102222
Width 18 mm; Height 10 mm; Length 55 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9052
Spine Wave, Inc.
11-9052 / 11-905210840642102239
Angle 10 deg; Length 55 mm; Height 12 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9053
Spine Wave, Inc.
11-9053 / 11-905310840642102246
Width 18 mm; Height 14 mm; Length 55 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9055
Spine Wave, Inc.
11-9055 / 11-905510840642102413
Angle 10 deg; Length 60 mm; Height 8 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9056
Spine Wave, Inc.
11-9056 / 11-905610840642102420
Width 18 mm; Height 10 mm; Length 60 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9057
Spine Wave, Inc.
11-9057 / 11-905710840642102437
Angle 10 deg; Length 60 mm; Height 12 mm; Width 18 mm
On the market
Abacus® Spacer System 11-9058
Spine Wave, Inc.
11-9058 / 11-905810840642102444
Width 18 mm; Height 14 mm; Length 60 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9066
Spine Wave, Inc.
11-9066 / 11-906610840642101522
Height 10 mm; Width 22 mm; Length 45 mm
On the market
Abacus® Spacer System 11-9067
Spine Wave, Inc.
11-9067 / 11-906710840642101539
Length 45 mm; Width 22 mm; Height 12 mm
On the market
Abacus® Spacer System 11-9068
Spine Wave, Inc.
11-9068 / 11-906810840642101546
Height 14 mm; Width 22 mm; Length 45 mm
On the market
Abacus® Spacer System 11-9071
Spine Wave, Inc.
11-9071 / 11-907110840642101829
Height 10 mm; Width 22 mm; Length 50 mm
On the market
Abacus® Spacer System 11-9072
Spine Wave, Inc.
11-9072 / 11-907210840642101836
Length 50 mm; Width 22 mm; Height 12 mm
On the market
Abacus® Spacer System 11-9073
Spine Wave, Inc.
11-9073 / 11-907310840642101843
Height 14 mm; Width 22 mm; Length 50 mm
On the market
Abacus® Spacer System 11-9075
Spine Wave, Inc.
11-9075 / 11-907510840642102116
Length 55 mm; Width 22 mm; Height 8 mm
On the market
Abacus® Spacer System 11-9076
Spine Wave, Inc.
11-9076 / 11-907610840642102123
Height 10 mm; Width 22 mm; Length 55 mm
On the market
Abacus® Spacer System 11-9077
Spine Wave, Inc.
11-9077 / 11-907710840642102130
Length 55 mm; Width 22 mm; Height 12 mm
On the market
Abacus® Spacer System 11-9078
Spine Wave, Inc.
11-9078 / 11-907810840642102147
Height 14 mm; Width 22 mm; Length 55 mm
On the market
Abacus® Spacer System 11-9081
Spine Wave, Inc.
11-9081 / 11-908110840642102581
Height 10 mm; Width 22 mm; Length 60 mm
On the market
Abacus® Spacer System 11-9082
Spine Wave, Inc.
11-9082 / 11-908210840642102598
Length 60 mm; Width 22 mm; Height 12 mm
On the market
Abacus® Spacer System 11-9090
Spine Wave, Inc.
11-9090 / 11-909010840642101669
Width 22 mm; Height 8 mm; Length 45 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9092
Spine Wave, Inc.
11-9092 / 11-909210840642101683
Width 22 mm; Height 12 mm; Length 45 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9093
Spine Wave, Inc.
11-9093 / 11-909310840642101690
Angle 10 deg; Length 45 mm; Height 14 mm; Width 22 mm
On the market
Abacus® Spacer System 11-9096
Spine Wave, Inc.
11-9096 / 11-909610840642101973
Angle 10 deg; Length 50 mm; Height 10 mm; Width 22 mm
On the market
Abacus® Spacer System 11-9097
Spine Wave, Inc.
11-9097 / 11-909710840642101980
Width 22 mm; Height 12 mm; Length 50 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9100
Spine Wave, Inc.
11-9100 / 11-910010840642102260
Width 22 mm; Height 8 mm; Length 55 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9101
Spine Wave, Inc.
11-9101 / 11-910110840642102277
Angle 10 deg; Length 55 mm; Height 10 mm; Width 22 mm
On the market
Abacus® Spacer System 11-9105
Spine Wave, Inc.
11-9105 / 11-910510840642102468
Width 22 mm; Height 8 mm; Length 60 mm; Angle 10 deg
On the market
Abacus® Spacer System 11-9106
Spine Wave, Inc.
11-9106 / 11-910610840642102475
Angle 10 deg; Length 60 mm; Height 10 mm; Width 22 mm
On the market
Abacus® Spacer System 11-9107
Spine Wave, Inc.
11-9107 / 11-910710840642102482
Width 22 mm; Height 12 mm; Length 60 mm; Angle 10 deg
On the market

Similar devices

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

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →