Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Australis Anterior Lumbar Cage System

K-Number: K202820 · 2020-12-22

ApplicantPrism Surgical Designs Pty, Ltd.
Decision Date2020-12-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Australis Anterior Lumbar Cage System is a medical device manufactured by Prism Surgical Designs Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-22 under approval number K202820. 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 Australis Anterior Lumbar Cage System?

Australis Anterior Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Prism Surgical Designs Pty, Ltd.. The 510(k) number is K202820.

When was Australis Anterior Lumbar Cage System approved by the FDA?

Australis Anterior Lumbar Cage System received FDA 510(k) clearance on 2020-12-22, under approval number K202820.

What company makes Australis Anterior Lumbar Cage System?

Australis Anterior Lumbar Cage System is manufactured by Prism Surgical Designs Pty, Ltd..

What is the FDA product code for Australis Anterior Lumbar Cage System?

The FDA product code for Australis Anterior Lumbar Cage System is MAX.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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.

↑