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FDA 510(k)

Bio2 CLM BG Bioactive Scaffold

K-Number: K152589 · 2016-01-12

ApplicantBio2 Technologies, Inc.
Decision Date2016-01-12
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bio2 CLM BG Bioactive Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Bio2 Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K152589. 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 Bio2 CLM BG Bioactive Scaffold?

Bio2 CLM BG Bioactive Scaffold is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Bio2 Technologies, Inc.. The 510(k) number is K152589.

When did Bio2 CLM BG Bioactive Scaffold receive FDA 510(k) clearance?

Bio2 CLM BG Bioactive Scaffold received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152589.

Who is the listed applicant for Bio2 CLM BG Bioactive Scaffold?

The FDA 510(k) record lists Bio2 Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bio2 CLM BG Bioactive Scaffold?

The FDA product code for Bio2 CLM BG Bioactive Scaffold is MQV.

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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