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FDA 510(k)

FOCUS Interbody System

K-Number: K221172 · 2022-10-14

ApplicantOc Medical Devices
Decision Date2022-10-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOCUS Interbody System is a medical device manufactured by Oc Medical Devices. It received FDA 510(k) clearance on 2022-10-14 under approval number K221172. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS Interbody System?

FOCUS Interbody System is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Oc Medical Devices. The 510(k) number is K221172.

When was FOCUS Interbody System approved by the FDA?

FOCUS Interbody System received FDA 510(k) clearance on 2022-10-14, under approval number K221172.

What company makes FOCUS Interbody System?

FOCUS Interbody System is manufactured by Oc Medical Devices.

What is the FDA product code for FOCUS Interbody System?

The FDA product code for FOCUS Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07586098 AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07581301 Administering Atropine Through Autoinjectors Within Ambulance Services for Poisoning Patients in Sri Lanka's North Central Province NOT_YET_RECRUITING NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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