FDA 510(k)

Sorrento Bone Graft Substitute

K-Number: K191074 · 2019-09-27

Decision Date2019-09-27

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Sorrento Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2019-09-27 under 510(k) 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. The listed applicant is Xenco Medical, LLC. The 510(k) number is K191074.

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

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

Who is the listed applicant for Sorrento Bone Graft Substitute?

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

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

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 ReconstructionCOMPLETED NCT05706909The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral HeadACTIVE_NOT_RECRUITING NCT07057817The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb SalvageRECRUITING NCT07059065FIBERGRAFT Aeridyan Posterolateral Fusion StudyRECRUITING NCT07569146Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone.COMPLETED NCT07646795Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative StudyACTIVE_NOT_RECRUITING

Other records listing Xenco Medical, LLC as applicant

K243673Xenco Medical CancelleX Cervical Interbody System K223059Xenco Medical InterAlign Cervical Interbody System K213456Xenco Medical Multilevel CerviKit K190364CancelleX Porous Titanium Lumbar Interbody Device K173933Sorrento Bioglass Bone Graft Substitute K180373CancelleX Porous Titanium Lumbar Interbody Device

View all 11 devices →

Related Devices (Code: MQV)

K260364Device 300419 StripGeistlich Pharma AG K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker Spine K253524Adaptos®Fuse Bone GraftBiomendex OY K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, 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.