Data / Medical devices / Israel / CarboFix Orthopedics, Ltd.
CarboFix Orthopedics, Ltd.: FDA-registered device maker in Herzeliya Central, Israel, 36 510(k) clearances
CarboFix Orthopedics, Ltd. is registered with the FDA (registration 9615128) in Herzeliya Central, Israel. It lists 13 device types. The FDA files 36 510(k) clearances under its listings, the newest dated October 9, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615128
- FEI number
- 3008820440
- Address
- 11 Hahoshlim ST., Herzeliya Central, Israel, 4672411
- Owner or operator
- CarboFix Orthopedics Ltd. (10035372)
- Roles
- Manufacturer
- First device listed
- February 24, 2011
- Registered through
- 2027
- Brand names listed
- CarboClear Cervical Plate System, CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement, CarboClear Hybrid Pedicle Screw System, CarboClear II Pedicle Screw System, CarboClear Lumbar Cage System, CarboClear Navigated Instruments, CarboClear Pedicle Screw System, CarboClear Vertebral Body Replacement (VBR) System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2026 | K263154 | CarboClear® Cervical Navigated Instruments | OLO | Substantially Equivalent | CarboFix Orhtopedics , Ltd. | accessdata.fda.gov |
| March 16, 2026 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | NKG | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| November 5, 2024 | K243106 | CarboClear® Hybrid Pedicle Screw System | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| August 1, 2024 | K233793 | CarboClear® X Pedicle Screw System | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| April 25, 2024 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| March 27, 2024 | K233989 | CarboClear® Posterior Cervical Screw System | NKG | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| January 10, 2024 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| July 26, 2023 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | ODP | Substantially Equivalent | Carbofix Orthpedics , Ltd. | accessdata.fda.gov |
| July 3, 2023 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| April 6, 2021 | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| January 15, 2021 | K203683 | CarboClear Lumbar Cage System | MAX | Substantially Equivalent | Carbofix Orthpedics , Ltd. | accessdata.fda.gov |
| October 8, 2020 | K201917 | Piccolo Composite Proximal Tibia Plate System | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| August 7, 2020 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| August 5, 2020 | K201251 | CarboClear Navigated Instruments | OLO | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| June 4, 2020 | K200883 | CarboClear® Cervical Plate System | KWQ | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| March 2, 2020 | K193378 | CarboClear Lumbar Cage System | MAX | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| October 11, 2019 | K192214 | CarboClear VBR System | MQP | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| September 19, 2019 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | PML | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| October 11, 2018 | K182015 | Piccolo Composite® Plate System | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| September 27, 2018 | K182377 | CarboClear® Pedicle Screw System | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| July 18, 2018 | K173487 | CarboClear® Pedicle Screw System | NKB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| December 28, 2017 | K173652 | Piccolo Composite Nailing System | HSB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| May 12, 2017 | K170401 | Piccolo Composite® Plate System | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| March 9, 2016 | K160002 | Piccolo Composite(R) Distal Volar Radius Plate System | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| January 6, 2016 | K153536 | Piccolo Composite® Nailing System | HSB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| July 28, 2015 | K151010 | Piccolo Composite Nailing System | HSB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| May 29, 2015 | K143496 | Piccolo Composite Plate System | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| October 3, 2013 | K132774 | PICCOLO COMPOSITE NAILING SYSTEM | HSB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| June 14, 2013 | K123810 | PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM | HSB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| February 27, 2013 | K130061 | PICCOLO COMPOSITE PLATE SYSTEM | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| November 26, 2012 | K120409 | PICCOLO COMPOSITE PLATE SYSTEM | HRS | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| May 3, 2011 | K111056 | PICCOLO COMPOSITE NAILING SYSTEM | HSB | Substantially Equivalent | CarboFix Orthopedics , Ltd. | accessdata.fda.gov |
| February 24, 2011 | K102597 | PICCOLO COMPOSITE PLATE SYSTEM | HRS | Substantially Equivalent | N.M.B. Medical Applications, Ltd. | accessdata.fda.gov |
| January 31, 2011 | K102369 | PICCOLO COMPOSITE NAILING SYSTEM | HSB | Substantially Equivalent | N.M.B. Medical Applications, Ltd. | accessdata.fda.gov |
| June 21, 2010 | K100497 | QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) | HSB | Substantially Equivalent | N.M.B. Medical Applications, Ltd. | accessdata.fda.gov |
| January 21, 2010 | K091425 | QUANTUM M COMPOSITE NAILING SYSTEM | HSB | Substantially Equivalent | N.M.B. Medical Applications, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 10, 2016 | 74229 | Class II | Terminated | Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Posterior Cervical Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Spinal Vertebral Body Replacement Device
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.