Cervical Spacer— 510(k) K182477

Name: FDA 510(k) clearance K182477
Creator: U.S. Food and Drug Administration
Published: 2019-01-28

Substantially Equivalent

Additive Implants, LLC

FDA 510(k) clearance K182477 for Cervical Spacer, Substantially Equivalent on 2019-01-28. Applicant: Additive Implants, LLC. Device class: 2.

Clearance details

Applicant: Additive Implants, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-09-10
Decision date: 2019-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pheonix, AZ, US

Download summary PDF View on FDA.gov ↗

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K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.