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FDA 510(k)

The Graft Bone Substitute

K-Number: K191737 · 2020-02-14

ApplicantPurgo Biologics, Inc.
Decision Date2020-02-14
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

The Graft Bone Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K191737. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Graft Bone Substitute?

The Graft Bone Substitute is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K191737.

When did The Graft Bone Substitute receive FDA 510(k) clearance?

The Graft Bone Substitute received FDA 510(k) clearance on 2020-02-14, under 510(k) number K191737.

Who is the listed applicant for The Graft Bone Substitute?

The FDA 510(k) record lists Purgo Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Graft Bone Substitute?

The FDA product code for The Graft Bone Substitute is NPM.

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.

NCT01234415Bone Substitute in the Multi Traumatized Nasal Septum ReconstructionCOMPLETEDNCT05706909The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral HeadACTIVE_NOT_RECRUITINGNCT07057817The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb SalvageRECRUITINGNCT07059065FIBERGRAFT Aeridyan Posterolateral Fusion StudyRECRUITINGNCT07569146Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone.COMPLETEDNCT07646795Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative StudyACTIVE_NOT_RECRUITING

Other records listing Purgo Biologics, Inc. 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.

K230305THE Graft CollagenK230091THE CoverK222549OpenTexK180992BiotexK173188The Graft Natural Bone Substitute

Related Devices (Code: NPM)

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.

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCK230305THE Graft CollagenPurgo Biologics, Inc.

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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