Orthopaedic Implant Company

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242995OIC Small / Mini Fragment Plate SystemOctober 23, 2024
K233531OIC FLEX-FIX™ SystemFebruary 2, 2024
K223761OIC Intramedullary Screw SystemFebruary 13, 2023
K223118OIC Variable Angle Small Fragment Locking Plate SystemJanuary 21, 2023
K212601DRPx Locking Distal Radius Plate SystemApril 5, 2022
K202971DRPx Locking Distal Radius Plate SystemMay 6, 2021
K211112OIC External Fixation SystemMay 5, 2021
K183682OIC External Fixation SystemApril 8, 2019
K182736OIC Suture Anchor SystemDecember 28, 2018
K181184OIC Intramedullary Nail SystemJuly 27, 2018
K171211OIC External Fixation SystemSeptember 27, 2017
K160222OIC Cervical PEEK SpacerDecember 7, 2016
K150655OIC Intramedullary Nail SystemJuly 9, 2015
K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEMJune 9, 2014
K113123OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEMJanuary 12, 2012