Cartiva, Inc

FDA Regulatory Profile

Cartiva, Inc appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0598-2025, Class II) was initiated on October 31, 2024. Its most recent 510(k) clearance was granted on September 4, 2019.

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