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FDA 510(k)

Acro Composites Interbody System

K-Number: K230478 · 2023-10-19

ApplicantAcro Composites, LLC
Decision Date2023-10-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acro Composites Interbody System is a medical device manufactured by Acro Composites, LLC. It received FDA 510(k) clearance on 2023-10-19 under approval number K230478. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acro Composites Interbody System?

Acro Composites Interbody System is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Acro Composites, LLC. The 510(k) number is K230478.

When was Acro Composites Interbody System approved by the FDA?

Acro Composites Interbody System received FDA 510(k) clearance on 2023-10-19, under approval number K230478.

What company makes Acro Composites Interbody System?

Acro Composites Interbody System is manufactured by Acro Composites, LLC.

What is the FDA product code for Acro Composites Interbody System?

The FDA product code for Acro Composites Interbody System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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