Align Cervical Interbody Fusion System
K-Number: K230639 · 2023-12-01
ApplicantAcuity Surgical Devices, LLC
Decision Date2023-12-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Align Cervical Interbody Fusion System is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2023-12-01 under approval number K230639. 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 Align Cervical Interbody Fusion System?
Align Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K230639.
When was Align Cervical Interbody Fusion System approved by the FDA?
Align Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-12-01, under approval number K230639.
What company makes Align Cervical Interbody Fusion System?
Align Cervical Interbody Fusion System is manufactured by Acuity Surgical Devices, LLC.
What is the FDA product code for Align Cervical Interbody Fusion System?
The FDA product code for Align Cervical Interbody Fusion System is ODP.
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
NCT07606196
The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases
COMPLETED
NCT05438719
MOTUS Total Joint Replacement Investigational Device Exemption Study
ACTIVE_NOT_RECRUITING
NCT04823858
3Spine Lumbar Fusion Real World Evidence Study
ACTIVE_NOT_RECRUITING
NCT07586098
AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 41879133
Medical Device Regulation - Who Does the FDA Serve?
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (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 Acuity Surgical Devices, LLC
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.