Toby Orthopaedics, Inc.

FDA Regulatory Profile

Toby Orthopaedics, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0599-2020, Class II) was initiated on June 5, 2013. Its most recent 510(k) clearance was granted on November 4, 2013.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0599-2020Class IIPANTERA Proximal Humerus Fracture Plate SystemJune 5, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K131834WOLF LONG BONE PLATE SYSTEMNovember 4, 2013
K081608PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)December 19, 2008