Sagemax Bioceramics, Inc.

FDA Regulatory Profile

Sagemax Bioceramics, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2356-2026, Class II) was initiated on December 11, 2025. Its most recent 510(k) clearance was granted on February 10, 2014.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2356-2026Class IINexxZr T Multi A3.5 W98-16mm, REF: 745451December 11, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K130991NEXXZR(TM)T AND NEXXZR(TM)SFebruary 10, 2014
K062695SAGEMAX Z-BLANKOctober 20, 2006