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FDA 510(k)

ENZA Zero-Profile Anterior Interbody Fusion

K-Number: K153720 · 2016-05-03

ApplicantCamber Spine Technologies
Decision Date2016-05-03
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENZA Zero-Profile Anterior Interbody Fusion is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2016-05-03 under approval number K153720. 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 Zero-Profile Anterior Interbody Fusion?

ENZA Zero-Profile Anterior Interbody Fusion is a medical device that received FDA 510(k) clearance on 2016-05-03. It is manufactured by Camber Spine Technologies. The 510(k) number is K153720.

When was ENZA Zero-Profile Anterior Interbody Fusion approved by the FDA?

ENZA Zero-Profile Anterior Interbody Fusion received FDA 510(k) clearance on 2016-05-03, under approval number K153720.

What company makes ENZA Zero-Profile Anterior Interbody Fusion?

ENZA Zero-Profile Anterior Interbody Fusion is manufactured by Camber Spine Technologies.

What is the FDA product code for ENZA Zero-Profile Anterior Interbody Fusion?

The FDA product code for ENZA Zero-Profile Anterior Interbody Fusion is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07608588 Recovery From Post-Stroke Aphasia With rTMS Targeting Left or Right Anterior Temporal Lobe 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

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 Camber Spine Technologies

K172446SPIRA-C Open Matrix Cervical Interbody K172064Ti-Diagon Oblique TLIF K170550Coveris Cervical Cage System K162986SPIRA Open Matrix ALIF K162121Siconus SI Joint Fixation System K173432ENZA-A Titanium ALIF

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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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