FDA 510(k)

HALF DOME Posterior Lumbar Interbody System

K-Number: K182877 · 2019-05-03

Decision Date2019-05-03

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HALF DOME Posterior Lumbar Interbody System is a medical device manufactured by Astura Medical, LLC. It received FDA 510(k) clearance on 2019-05-03 under approval number K182877. 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 HALF DOME Posterior Lumbar Interbody System?

HALF DOME Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Astura Medical, LLC. The 510(k) number is K182877.

When was HALF DOME Posterior Lumbar Interbody System approved by the FDA?

HALF DOME Posterior Lumbar Interbody System received FDA 510(k) clearance on 2019-05-03, under approval number K182877.

What company makes HALF DOME Posterior Lumbar Interbody System?

HALF DOME Posterior Lumbar Interbody System is manufactured by Astura Medical, LLC.

What is the FDA product code for HALF DOME Posterior Lumbar Interbody System?

The FDA product code for HALF DOME Posterior Lumbar 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 NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Astura Medical, LLC

K182239OLYMPIC Posterior Spinal Fixation System K181139OLYMPIC Posterior Spinal Fixation System K190426ALTA Anterior Cervical Corpectomy System K202065DOLOMITE Anterior Cervical Stabilization System K192492EL CAPITAN Anterior Lumber Interbody System K192006SIRION Lateral Lumbar Interbody System

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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.