Company · IL
CarboFix Orthopedics , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 12 |
| HRS | Plate, Fixation, Bone | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 7 |
| NKG | Posterior Cervical Screw System | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 2026 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System CarboFix Orthopedics , Ltd., IL | NKG |
| Nov 5, 2024 | K243106 | CarboClear® Hybrid Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Aug 1, 2024 | K233793 | CarboClear® X Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Apr 25, 2024 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicl CarboFix Orthopedics , Ltd., IL | NKB |
| Mar 27, 2024 | K233989 | CarboClear® Posterior Cervical Screw System CarboFix Orthopedics , Ltd., IL | NKG |
| Jan 10, 2024 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments CarboFix Orthopedics , Ltd., IL | NKB |
| Oct 10, 2023 | K232341 | CarboClear® Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Jul 3, 2023 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Apr 6, 2021 | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments CarboFix Orthopedics , Ltd., IL | NKB |
| Nov 25, 2020 | K203317 | CarboClear X Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Oct 8, 2020 | K201917 | Piccolo Composite Proximal Tibia Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Aug 7, 2020 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Aug 5, 2020 | K201251 | CarboClear Navigated Instruments CarboFix Orthopedics , Ltd., IL | OLO |
| Jun 4, 2020 | K200883 | CarboClear® Cervical Plate System CarboFix Orthopedics , Ltd., IL | KWQ |
| Apr 30, 2020 | K200519 | CarboClear® II Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Mar 2, 2020 | K193378 | CarboClear Lumbar Cage System CarboFix Orthopedics , Ltd., IL | MAX |
| Oct 11, 2019 | K192214 | CarboClear VBR System CarboFix Orthopedics , Ltd., IL | MQP |
| Sep 19, 2019 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws CarboFix Orthopedics , Ltd., IL | PML |
| Oct 11, 2018 | K182015 | Piccolo Composite® Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Sep 27, 2018 | K182377 | CarboClear® Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Jul 18, 2018 | K173487 | CarboClear® Pedicle Screw System CarboFix Orthopedics , Ltd., IL | NKB |
| Dec 28, 2017 | K173652 | Piccolo Composite Nailing System CarboFix Orthopedics , Ltd., IL | HSB |
| May 12, 2017 | K170401 | Piccolo Composite® Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Mar 9, 2016 | K160002 | Piccolo Composite(R) Distal Volar Radius Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Jan 6, 2016 | K153536 | Piccolo Composite® Nailing System CarboFix Orthopedics , Ltd., IL | HSB |
| Jul 28, 2015 | K151010 | Piccolo Composite Nailing System CarboFix Orthopedics , Ltd., IL | HSB |
| May 29, 2015 | K143496 | Piccolo Composite Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Oct 3, 2013 | K132774 | PICCOLO COMPOSITE NAILING SYSTEM CarboFix Orthopedics , Ltd., IL | HSB |
| Jun 14, 2013 | K123810 | PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CarboFix Orthopedics , Ltd., IL | HSB |
| Feb 27, 2013 | K130061 | PICCOLO COMPOSITE PLATE SYSTEM CarboFix Orthopedics , Ltd., IL | HRS |
| Nov 26, 2012 | K120409 | PICCOLO COMPOSITE PLATE SYSTEM CarboFix Orthopedics , Ltd., IL | HRS |
| May 3, 2011 | K111056 | PICCOLO COMPOSITE NAILING SYSTEM CarboFix Orthopedics , Ltd., IL | HSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2016 | CarboFix Orthopedics, Ltd. 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. Terminated |
HSB | K102369 K111056 +2 |