Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cervical Spacer

K-Number: K182477 · 2019-01-28

ApplicantAdditive Implants, LLC
Decision Date2019-01-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Spacer is a medical device manufactured by Additive Implants, LLC. It received FDA 510(k) clearance on 2019-01-28 under approval number K182477. 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 Cervical Spacer?

Cervical Spacer is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by Additive Implants, LLC. The 510(k) number is K182477.

When was Cervical Spacer approved by the FDA?

Cervical Spacer received FDA 510(k) clearance on 2019-01-28, under approval number K182477.

What company makes Cervical Spacer?

Cervical Spacer is manufactured by Additive Implants, LLC.

What is the FDA product code for Cervical Spacer?

The FDA product code for Cervical Spacer is ODP.

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.

↑