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FDA 510(k)

Vitoss Bioactive (BA) Injectable

K-Number: K163621 · 2017-05-02

ApplicantOrthovita, Inc.
Decision Date2017-05-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vitoss Bioactive (BA) Injectable is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K163621. 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 Bioactive (BA) Injectable?

Vitoss Bioactive (BA) Injectable is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Orthovita, Inc.. The 510(k) number is K163621.

When did Vitoss Bioactive (BA) Injectable receive FDA 510(k) clearance?

Vitoss Bioactive (BA) Injectable received FDA 510(k) clearance on 2017-05-02, under 510(k) number K163621.

Who is the listed applicant for Vitoss Bioactive (BA) Injectable?

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 Bioactive (BA) Injectable?

The FDA product code for Vitoss Bioactive (BA) Injectable is MQV.

Other records listing Orthovita, Inc. as applicant

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.

K161447HydroSet XTK153608Vitoss BiModal Bone Graft Substitute Foam Strip

Related Devices (Code: MQV)

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.

K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ 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 SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ 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.

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