FDA 510(k)

Vitoss BiModal Bone Graft Substitute Foam Strip

K-Number: K153608 · 2016-02-12

Decision Date2016-02-12

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vitoss BiModal Bone Graft Substitute Foam Strip is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153608. 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 Vitoss BiModal Bone Graft Substitute Foam Strip?

Vitoss BiModal Bone Graft Substitute Foam Strip is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Orthovita, Inc.. The 510(k) number is K153608.

When did Vitoss BiModal Bone Graft Substitute Foam Strip receive FDA 510(k) clearance?

Vitoss BiModal Bone Graft Substitute Foam Strip received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153608.

Who is the listed applicant for Vitoss BiModal Bone Graft Substitute Foam Strip?

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

What is the FDA product code for Vitoss BiModal Bone Graft Substitute Foam Strip?

The FDA product code for Vitoss BiModal Bone Graft Substitute Foam Strip 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 NCT03118505A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal ConditionsACTIVE_NOT_RECRUITING 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

Other records listing Orthovita, Inc. as applicant

K163621Vitoss Bioactive (BA) Injectable K161447HydroSet XT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.