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FDA 510(k)

SPIRA® Anterior Lumbar Spacers

K-Number: K234077 · 2024-07-12

ApplicantCamber Spine Technologies
Decision Date2024-07-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRA® Anterior Lumbar Spacers is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2024-07-12 under approval number K234077. 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 SPIRA® Anterior Lumbar Spacers?

SPIRA® Anterior Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Camber Spine Technologies. The 510(k) number is K234077.

When was SPIRA® Anterior Lumbar Spacers approved by the FDA?

SPIRA® Anterior Lumbar Spacers received FDA 510(k) clearance on 2024-07-12, under approval number K234077.

What company makes SPIRA® Anterior Lumbar Spacers?

SPIRA® Anterior Lumbar Spacers is manufactured by Camber Spine Technologies.

What is the FDA product code for SPIRA® Anterior Lumbar Spacers?

The FDA product code for SPIRA® Anterior Lumbar Spacers is MAX.

Related Clinical Trials

NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

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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.

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