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FDA 510(k)

OIC External Fixation System

K-Number: K211112 · 2021-05-05

ApplicantOrthopaedic Implant Company
Decision Date2021-05-05
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OIC External Fixation System is a medical device manufactured by Orthopaedic Implant Company. It received FDA 510(k) clearance on 2021-05-05 under approval number K211112. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OIC External Fixation System?

OIC External Fixation System is a medical device that received FDA 510(k) clearance on 2021-05-05. It is manufactured by Orthopaedic Implant Company. The 510(k) number is K211112.

When was OIC External Fixation System approved by the FDA?

OIC External Fixation System received FDA 510(k) clearance on 2021-05-05, under approval number K211112.

What company makes OIC External Fixation System?

OIC External Fixation System is manufactured by Orthopaedic Implant Company.

What is the FDA product code for OIC External Fixation System?

The FDA product code for OIC External Fixation System is KTT.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

Other Devices by Orthopaedic Implant Company

K171211OIC External Fixation System K183682OIC External Fixation System K202971DRPx Locking Distal Radius Plate System K212601DRPx Locking Distal Radius Plate System K223761OIC Intramedullary Screw System K223118OIC Variable Angle Small Fragment Locking Plate System

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Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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.

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