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FDA 510(k)

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

K-Number: K233490 · 2023-12-05

ApplicantBioventus, LLC
Decision Date2023-12-05
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus, LLC. It received FDA 510(k) clearance on 2023-12-05 under 510(k) number K233490. 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 SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty?

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Bioventus, LLC. The 510(k) number is K233490.

When did SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty receive FDA 510(k) clearance?

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty received FDA 510(k) clearance on 2023-12-05, under 510(k) number K233490.

Who is the listed applicant for SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty?

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

What is the FDA product code for SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty?

The FDA product code for SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty is MQV.

Other records listing Bioventus, LLC as applicant

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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

View on FDA Database →

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

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