Altus Spine Interbody Standalone Fusion System— 510(k) K211837

Name: FDA 510(k) clearance K211837
Creator: U.S. Food and Drug Administration
Published: 2022-04-19

Substantially Equivalent

Altus Partners, LLC

FDA 510(k) clearance K211837 for Altus Spine Interbody Standalone Fusion System, Substantially Equivalent on 2022-04-19. Applicant: Altus Partners, LLC. Device class: 2.

Clearance details

Applicant: Altus Partners, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-06-14
Decision date: 2022-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10

More clearances from Altus Partners, LLC

view all

K243419 — Altus Spine Navigation System2025-05-08
K211027 — Altus Spine Pedicle Screw System2022-09-16
K210887 — Altus Spine Sochi OCT Spinal System2021-08-20
K200922 — Altus Spine HA Pedicle Screw System2021-01-26
K200322 — Altus Spine Pedicle Screw System2020-06-02

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.