Orthorebirth Co Ltd

FDA Regulatory Profile

Orthorebirth Co Ltd appears in FDA public data with 2 recalls, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2132-2026, Class II) was initiated on March 25, 2026. Its most recent 510(k) clearance was granted on March 4, 2024.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2132-2026Class IIZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-ZMarch 25, 2026
Z-2131-2026Class IIBioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0March 25, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K240453ReBOSSISMarch 4, 2024
K172573ReBOSSIS85December 15, 2017
K170620ReBOSSIS85June 23, 2017
K142090REBOSSISOctober 29, 2014