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FDA 510(k)

ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)

K-Number: K221324 · 2023-03-30

ApplicantCamber Spine Technologies
Decision Date2023-03-30
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2023-03-30 under approval number K221324. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)?

ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Camber Spine Technologies. The 510(k) number is K221324.

When was ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) approved by the FDA?

ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) received FDA 510(k) clearance on 2023-03-30, under approval number K221324.

What company makes ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)?

ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is manufactured by Camber Spine Technologies.

What is the FDA product code for ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)?

The FDA product code for ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is OVD.

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 NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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 Camber Spine Technologies

K153720ENZA Zero-Profile Anterior Interbody Fusion K172446SPIRA-C Open Matrix Cervical Interbody K172064Ti-Diagon Oblique TLIF K170550Coveris Cervical Cage System K162986SPIRA Open Matrix ALIF K162121Siconus SI Joint Fixation System

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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