OIC Intramedullary Nail System
K-Number: K181184 · 2018-07-27
ApplicantThe Orthopaedic Implant Company
Decision Date2018-07-27
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OIC Intramedullary Nail System is a medical device manufactured by The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2018-07-27 under approval number K181184. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OIC Intramedullary Nail System?
OIC Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by The Orthopaedic Implant Company. The 510(k) number is K181184.
When was OIC Intramedullary Nail System approved by the FDA?
OIC Intramedullary Nail System received FDA 510(k) clearance on 2018-07-27, under approval number K181184.
What company makes OIC Intramedullary Nail System?
OIC Intramedullary Nail System is manufactured by The Orthopaedic Implant Company.
What is the FDA product code for OIC Intramedullary Nail System?
The FDA product code for OIC Intramedullary Nail System is HSB.
Related Clinical Trials
Other Devices by The Orthopaedic Implant Company
Related Devices (Code: HSB)
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K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC
K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.
K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.