Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Additive Implants, LLC. It received FDA 510(k) clearance on 2019-01-28 under 510(k) 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. The listed applicant is Additive Implants, LLC. The 510(k) number is K182477.

When did Cervical Spacer receive FDA 510(k) clearance?

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

Who is the listed applicant for Cervical Spacer?

The FDA 510(k) record lists Additive Implants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Spacer?

The FDA product code for Cervical Spacer is ODP.

Other records listing Additive Implants, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211111SureMAX-SA Cervical Standalone SystemK193359SureMAX Family of Cervical Spacers

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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.

↑