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FDA 510(k)

SIRION Lateral Lumbar Interbody Fusion

K-Number: K202495 · 2021-01-06

ApplicantAstura Medical, LLC
Decision Date2021-01-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIRION Lateral Lumbar Interbody Fusion is a medical device manufactured by Astura Medical, LLC. It received FDA 510(k) clearance on 2021-01-06 under approval number K202495. 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 SIRION Lateral Lumbar Interbody Fusion?

SIRION Lateral Lumbar Interbody Fusion is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Astura Medical, LLC. The 510(k) number is K202495.

When was SIRION Lateral Lumbar Interbody Fusion approved by the FDA?

SIRION Lateral Lumbar Interbody Fusion received FDA 510(k) clearance on 2021-01-06, under approval number K202495.

What company makes SIRION Lateral Lumbar Interbody Fusion?

SIRION Lateral Lumbar Interbody Fusion is manufactured by Astura Medical, LLC.

What is the FDA product code for SIRION Lateral Lumbar Interbody Fusion?

The FDA product code for SIRION Lateral Lumbar Interbody Fusion is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) 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 K182877HALF DOME Posterior Lumbar Interbody System K202065DOLOMITE Anterior Cervical Stabilization System K192492EL CAPITAN Anterior Lumber Interbody System

View all 8 devices →

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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