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FDA 510(k)

BonOs® Inject Bone Cement; NEO Pedicle Screw System™

K-Number: K222256 · 2022-08-26

ApplicantNeo Medical SA
Decision Date2022-08-26
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BonOs® Inject Bone Cement; NEO Pedicle Screw System™ is the device name listed in this FDA 510(k) record. The listed applicant is Neo Medical SA. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K222256. 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 BonOs® Inject Bone Cement; NEO Pedicle Screw System™?

BonOs® Inject Bone Cement; NEO Pedicle Screw System™ is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Neo Medical SA. The 510(k) number is K222256.

When did BonOs® Inject Bone Cement; NEO Pedicle Screw System™ receive FDA 510(k) clearance?

BonOs® Inject Bone Cement; NEO Pedicle Screw System™ received FDA 510(k) clearance on 2022-08-26, under 510(k) number K222256.

Who is the listed applicant for BonOs® Inject Bone Cement; NEO Pedicle Screw System™?

The FDA 510(k) record lists Neo Medical SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BonOs® Inject Bone Cement; NEO Pedicle Screw System™?

The FDA product code for BonOs® Inject Bone Cement; NEO Pedicle Screw System™ is PML.

Other records listing Neo Medical SA 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.

K243693NEO Pedicle Screw System™K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemK191796Neo Cage SystemK181048Neo Cage System TMK171582NEO Pedicle Screw System™

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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