Altus Spine Cervical Interbody Fusion System— 510(k) K172253

Name: FDA 510(k) clearance K172253
Creator: U.S. Food and Drug Administration
Published: 2017-11-21

Substantially Equivalent

Altus Partners, LLC

FDA 510(k) clearance K172253 for Altus Spine Cervical Interbody Fusion System, Substantially Equivalent on 2017-11-21. Applicant: Altus Partners, LLC. Device class: 2.

Clearance details

Applicant: Altus Partners, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-07-26
Decision date: 2017-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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

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K211837 — Altus Spine Interbody Standalone Fusion System2022-04-19
K210887 — Altus Spine Sochi OCT Spinal System2021-08-20
K200922 — Altus Spine HA Pedicle Screw System2021-01-26

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.