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FDA 510(k)

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

K-Number: K190526 · 2019-09-19

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2019-09-19
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2019-09-19 under 510(k) number K190526. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is a medical device that received FDA 510(k) clearance on 2019-09-19. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K190526.

When did High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws receive FDA 510(k) clearance?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws received FDA 510(k) clearance on 2019-09-19, under 510(k) number K190526.

Who is the listed applicant for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

The FDA 510(k) record lists CarboFix Orthopedics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

The FDA product code for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is PML.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07408726Monoaxial vs. Polyaxial Percutaneous Hybrid StabilizationNOT_YET_RECRUITING

Other records listing CarboFix Orthopedics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemK243106CarboClear® Hybrid Pedicle Screw SystemK233793CarboClear® X Pedicle Screw SystemK240846CarboClear® 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 CementK233989CarboClear® Posterior Cervical Screw SystemK233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

View all 25 devices →

Related Devices (Code: PML)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura MedicalK241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USAK230774PERLA® TL System; TEKTONA® HV US Bone CementSpineartK222789VADER® Pedicle System, G21 CementIcotec AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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