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Cartiva, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0598-2025Class IICartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mmOctober 31, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K192156Cartiva SCI instrumentation setSeptember 4, 2019
K181348Cartiva SCI Disposable Instrumentation SetJune 20, 2018
K142490ProxiFuse Hammer Toe DeviceDecember 15, 2014