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CarboClear VBR System

by Carbofix Orthopedics Ltd

510(k) K192214

CarboClear VBR System is a Class II device made by Carbofix Orthopedics Ltd, cleared under FDA 510(k) K192214 on 11 Oct 2019, 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 NumberK192214 Date11 Oct 2019ClearedStatusActive

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  • Withdrawn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
MQP
FDA applicant
CarboFix Orthopedics , Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3060
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 K192214

38 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 K192214
UDI-DISize and differences
CarboClear Vertebral Body Replacement System Patient Specific VBR Spacer
CARBOFIX ORTHOPEDICS LTD
SP0011 / Patient Specific VBR Spacer07290110209841 —On the market
CarboClear Vertebral Body Replacement System VBR Insertion Handle
CARBOFIX ORTHOPEDICS LTD
VBRH10270 / VBR Insertion Handle07290110206147 —On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722030 / VBR Spacer07290110205782
Height 30 mm; Outer Diameter 22 mm; Outer Diameter 27 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722035 / VBR Spacer07290110205799
Height 35 mm; Outer Diameter 27 mm; Outer Diameter 22 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722040 / VBR Spacer07290110205805
Height 40 mm; Outer Diameter 22 mm; Outer Diameter 27 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722045 / VBR Spacer07290110205812
Height 45 mm; Outer Diameter 27 mm; Outer Diameter 22 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722050 / VBR Spacer07290110205829
Height 50 mm; Outer Diameter 22 mm; Outer Diameter 27 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722055 / VBR Spacer07290110205836
Height 55 mm; Outer Diameter 27 mm; Outer Diameter 22 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722060 / VBR Spacer07290110205843
Height 60 mm; Outer Diameter 22 mm; Outer Diameter 27 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722065 / VBR Spacer07290110205850
Height 65 mm; Outer Diameter 27 mm; Outer Diameter 22 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722070 / VBR Spacer07290110205867
Height 70 mm; Outer Diameter 22 mm; Outer Diameter 27 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722075 / VBR Spacer07290110205874
Height 75 mm; Outer Diameter 27 mm; Outer Diameter 22 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722080 / VBR Spacer07290110205881
Height 80 mm; Outer Diameter 22 mm; Outer Diameter 27 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR2722085 / VBR Spacer07290110205898
Height 85 mm; Outer Diameter 27 mm; Outer Diameter 22 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025030 / VBR Spacer07290110205904
Outer Diameter 25 mm; Outer Diameter 30 mm; Height 30 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025035 / VBR Spacer07290110205911
Height 35 mm; Outer Diameter 30 mm; Outer Diameter 25 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025040 / VBR Spacer07290110205928
Outer Diameter 25 mm; Outer Diameter 30 mm; Height 40 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025045 / VBR Spacer07290110205935
Height 45 mm; Outer Diameter 30 mm; Outer Diameter 25 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025050 / VBR Spacer07290110205942
Height 50 mm; Outer Diameter 25 mm; Outer Diameter 30 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025055 / VBR Spacer07290110205959
Height 55 mm; Outer Diameter 30 mm; Outer Diameter 25 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025060 / VBR Spacer07290110205966
Height 60 mm; Outer Diameter 25 mm; Outer Diameter 30 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025065 / VBR Spacer07290110205973
Height 65 mm; Outer Diameter 30 mm; Outer Diameter 25 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025070 / VBR Spacer07290110205980
Height 70 mm; Outer Diameter 25 mm; Outer Diameter 30 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025075 / VBR Spacer07290110205997
Height 75 mm; Outer Diameter 30 mm; Outer Diameter 25 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025080 / VBR Spacer07290110206000
Height 80 mm; Outer Diameter 25 mm; Outer Diameter 30 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3025085 / VBR Spacer07290110206017
Height 85 mm; Outer Diameter 30 mm; Outer Diameter 25 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527530 / VBR Spacer07290110206024
Outer Diameter 27.5 mm; Outer Diameter 35 mm; Height 30 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527535 / VBR Spacer07290110206031
Height 35 mm; Outer Diameter 35 mm; Outer Diameter 27.5 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527540 / VBR Spacer07290110206048
Height 40 mm; Outer Diameter 27.5 mm; Outer Diameter 35 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527545 / VBR Spacer07290110206055
Height 45 mm; Outer Diameter 35 mm; Outer Diameter 27.5 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527550 / VBR Spacer07290110206062
Height 50 mm; Outer Diameter 27.5 mm; Outer Diameter 35 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527555 / VBR Spacer07290110206079
Height 55 mm; Outer Diameter 35 mm; Outer Diameter 27.5 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527560 / VBR Spacer07290110206086
Height 60 mm; Outer Diameter 27.5 mm; Outer Diameter 35 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527565 / VBR Spacer07290110206093
Height 65 mm; Outer Diameter 35 mm; Outer Diameter 27.5 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527570 / VBR Spacer07290110206109
Height 70 mm; Outer Diameter 27.5 mm; Outer Diameter 35 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527575 / VBR Spacer07290110206116
Height 75 mm; Outer Diameter 35 mm; Outer Diameter 27.5 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527580 / VBR Spacer07290110206123
Height 80 mm; Outer Diameter 27.5 mm; Outer Diameter 35 mm
On the market
CarboClear Vertebral Body Replacement System VBR Spacer
CARBOFIX ORTHOPEDICS LTD
VBR3527585 / VBR Spacer07290110206130
Height 85 mm; Outer Diameter 35 mm; Outer Diameter 27.5 mm
On the market

Similar devices

Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).

Other devices from Carbofix Orthopedics Ltd

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