510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CarboFix Orthopedics Inc.

Richardson, TX, US

CarboFix Orthopedics Inc. appears in FDA device records in Richardson, TX. FDA records list 32 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
32
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 32 510(k) clearances for CarboFix Orthopedics Inc. between 2011 and 2026. The busiest year on record is 2020, with 7. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for CarboFix Orthopedics Inc., by decision year
YearClearances
20111
20121
20133
20152
20162
20172
20183
20192
20207
20211
20232
20245
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemNKGSubstantially Equivalent
K243106CarboClear® Hybrid Pedicle Screw SystemNKBSubstantially Equivalent
K233793CarboClear® X Pedicle Screw SystemNKBSubstantially Equivalent
K240846CarboClear® 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 CementNKBSubstantially Equivalent
K233989CarboClear® Posterior Cervical Screw SystemNKGSubstantially Equivalent
K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsNKBSubstantially Equivalent
K232341CarboClear® Pedicle Screw SystemNKBSubstantially Equivalent
K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone CementNKBSubstantially Equivalent
K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsNKBSubstantially Equivalent
K203317CarboClear X Pedicle Screw SystemNKBSubstantially Equivalent
K201917Piccolo Composite Proximal Tibia Plate SystemHRSSubstantially Equivalent
K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemNKBSubstantially Equivalent
K201251CarboClear Navigated InstrumentsOLOSubstantially Equivalent
K200883CarboClear® Cervical Plate SystemKWQSubstantially Equivalent
K200519CarboClear® II Pedicle Screw SystemNKBSubstantially Equivalent
K193378CarboClear Lumbar Cage SystemMAXSubstantially Equivalent
K192214CarboClear VBR SystemMQPSubstantially Equivalent
K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsPMLSubstantially Equivalent
K182015Piccolo Composite® Plate SystemHRSSubstantially Equivalent
K182377CarboClear® Pedicle Screw SystemNKBSubstantially Equivalent
K173487CarboClear® Pedicle Screw SystemNKBSubstantially Equivalent
K173652Piccolo Composite Nailing SystemHSBSubstantially Equivalent
K170401Piccolo Composite® Plate SystemHRSSubstantially Equivalent
K160002Piccolo Composite(R) Distal Volar Radius Plate SystemHRSSubstantially Equivalent
K153536Piccolo Composite® Nailing SystemHSBSubstantially Equivalent
K151010Piccolo Composite Nailing SystemHSBSubstantially Equivalent
K143496Piccolo Composite Plate SystemHRSSubstantially Equivalent
K132774PICCOLO COMPOSITE NAILING SYSTEMHSBSubstantially Equivalent
K123810PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEMHSBSubstantially Equivalent
K130061PICCOLO COMPOSITE PLATE SYSTEMHRSSubstantially Equivalent
K120409PICCOLO COMPOSITE PLATE SYSTEMHRSSubstantially Equivalent
K111056PICCOLO COMPOSITE NAILING SYSTEMHSBSubstantially Equivalent

Registered establishments

FDA registered establishments for CarboFix Orthopedics Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30094376643009437664CarboFix Orthopedics Inc.903 N Bowser Rd Ste 330, Richardson, TX 75081 US2026No device listings on this registration
96151283008820440CarboFix Orthopedics, Ltd.11 HAHOSHLIM ST., Herzeliya Central 4672411 IL2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1991-2016Piccolo 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.Class IITerminated

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain