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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 a medical device manufactured by Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2020-02-14 under approval 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. It is manufactured by Purgo Biologics, Inc.. The 510(k) number is K191737.

When was The Graft Bone Substitute approved by the FDA?

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

What company makes The Graft Bone Substitute?

The Graft Bone Substitute is manufactured by Purgo Biologics, Inc..

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

NCT01234415 Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction COMPLETED NCT07059065 FIBERGRAFT Aeridyan Posterolateral Fusion Study RECRUITING NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT05706909 The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head ACTIVE_NOT_RECRUITING

Other Devices by Purgo Biologics, Inc.

K173188The Graft Natural Bone Substitute K180992Biotex K230091THE Cover K222549OpenTex K230305THE Graft Collagen

Related Devices (Code: NPM)

K151542A-OssHiossen, Inc. K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc. K163714OSSIX BONEDatum Dental, Ltd. K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, 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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