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FDA 510(k)

Tailored-C Cervical Interbody Fusion System

K-Number: K200458 · 2020-12-28

ApplicantBespoke Technologies
Decision Date2020-12-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tailored-C Cervical Interbody Fusion System is a medical device manufactured by Bespoke Technologies. It received FDA 510(k) clearance on 2020-12-28 under approval number K200458. 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 Tailored-C Cervical Interbody Fusion System?

Tailored-C Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by Bespoke Technologies. The 510(k) number is K200458.

When was Tailored-C Cervical Interbody Fusion System approved by the FDA?

Tailored-C Cervical Interbody Fusion System received FDA 510(k) clearance on 2020-12-28, under approval number K200458.

What company makes Tailored-C Cervical Interbody Fusion System?

Tailored-C Cervical Interbody Fusion System is manufactured by Bespoke Technologies.

What is the FDA product code for Tailored-C Cervical Interbody Fusion System?

The FDA product code for Tailored-C Cervical Interbody Fusion System is ODP.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING 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 NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_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

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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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