Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sorrento Bone Graft Substitute

K-Number: K191074 · 2019-09-27

ApplicantXenco Medical, LLC
Decision Date2019-09-27
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sorrento Bone Graft Substitute is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2019-09-27 under approval number K191074. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sorrento Bone Graft Substitute?

Sorrento Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Xenco Medical, LLC. The 510(k) number is K191074.

When was Sorrento Bone Graft Substitute approved by the FDA?

Sorrento Bone Graft Substitute received FDA 510(k) clearance on 2019-09-27, under approval number K191074.

What company makes Sorrento Bone Graft Substitute?

Sorrento Bone Graft Substitute is manufactured by Xenco Medical, LLC.

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

The FDA product code for Sorrento Bone Graft Substitute is MQV.

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 Xenco Medical, LLC

K160313Xenco Medical Cervical Interbody System K161478Xenco Medical Posterior Cervical System K160986Xenco Medical Pedicle Screw System K170611SETx Pedicle Screw System K173933Sorrento Bioglass Bone Graft Substitute K180373CancelleX Porous Titanium Lumbar Interbody Device

View all 11 devices →

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K161447HydroSet XTOrthovita, Inc. K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp.

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.

↑