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FDA 510(k)

The Graft Natural Bone Substitute

K-Number: K173188 · 2018-07-20

ApplicantPurgo Biologics, Inc.
Decision Date2018-07-20
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

The Graft Natural Bone Substitute is a medical device manufactured by Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2018-07-20 under approval number K173188. 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 Natural Bone Substitute?

The Graft Natural Bone Substitute is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Purgo Biologics, Inc.. The 510(k) number is K173188.

When was The Graft Natural Bone Substitute approved by the FDA?

The Graft Natural Bone Substitute received FDA 510(k) clearance on 2018-07-20, under approval number K173188.

What company makes The Graft Natural Bone Substitute?

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

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

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

Related Clinical Trials

NCT07595198 Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction NOT_YET_RECRUITING NCT01234415 Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction COMPLETED NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING 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.

K180992Biotex K191737The Graft Bone Substitute 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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