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 a medical device manufactured by Bioventus, LLC. It received FDA 510(k) clearance on 2023-12-05 under approval 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. It is manufactured by Bioventus, LLC. The 510(k) number is K233490.
When was SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty approved by the FDA?
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty received FDA 510(k) clearance on 2023-12-05, under approval number K233490.
What company makes SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty?
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty is manufactured by Bioventus, LLC.
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 Devices by Bioventus, LLC
Related Devices (Code: MQV)
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.