Acu-Sinch Knotless Mini
K-Number: K243624 · 2025-01-23
ApplicantAcumed, LLC
Decision Date2025-01-23
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Acu-Sinch Knotless Mini is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2025-01-23 under approval number K243624. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Acu-Sinch Knotless Mini?
Acu-Sinch Knotless Mini is a medical device that received FDA 510(k) clearance on 2025-01-23. It is manufactured by Acumed, LLC. The 510(k) number is K243624.
When was Acu-Sinch Knotless Mini approved by the FDA?
Acu-Sinch Knotless Mini received FDA 510(k) clearance on 2025-01-23, under approval number K243624.
What company makes Acu-Sinch Knotless Mini?
Acu-Sinch Knotless Mini is manufactured by Acumed, LLC.
What is the FDA product code for Acu-Sinch Knotless Mini?
The FDA product code for Acu-Sinch Knotless Mini is HTN.
Other Devices by Acumed, LLC
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K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
K212990Acumed Ankle Syndesmosis Repair System
K230744Acumed Acutrak 3 Headless Compression Screw System
K233311Acumed Wrist Plating System
K252356The Acumed Wrist Fixation System - 2.4mm Screws
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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.