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FDA 510(k)

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY

K-Number: K122868 · 2013-04-19

ApplicantSynergy Biomedical, LLC
Decision Date2013-04-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Biomedical, LLC. It received FDA 510(k) clearance on 2013-04-19 under 510(k) number K122868. 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 BIOSPHERE BIOACTIVE BONE GRAFT PUTTY?

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY is a medical device that received FDA 510(k) clearance on 2013-04-19. The listed applicant is Synergy Biomedical, LLC. The 510(k) number is K122868.

When did BIOSPHERE BIOACTIVE BONE GRAFT PUTTY receive FDA 510(k) clearance?

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY received FDA 510(k) clearance on 2013-04-19, under 510(k) number K122868.

Who is the listed applicant for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY?

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

What is the FDA product code for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY?

The FDA product code for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY is MQV.

Related Clinical Trials

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Other records listing Synergy Biomedical, LLC 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.

K173301BioSphere MIS Putty (BioSphere MIS)

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.

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.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.

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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