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FDA 510(k)

Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices

K-Number: K223065 · 2022-10-26

ApplicantAdcura, Inc.
Decision Date2022-10-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices is a medical device manufactured by Adcura, Inc.. It received FDA 510(k) clearance on 2022-10-26 under approval number K223065. 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 Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices?

Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Adcura, Inc.. The 510(k) number is K223065.

When was Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices approved by the FDA?

Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices received FDA 510(k) clearance on 2022-10-26, under approval number K223065.

What company makes Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices?

Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices is manufactured by Adcura, Inc..

What is the FDA product code for Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices?

The FDA product code for Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices 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)

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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