DeGen Medical Latitude-C AM Cervical Interbody Fusion System— 510(k) K252737

Name: FDA 510(k) clearance K252737
Creator: U.S. Food and Drug Administration
Published: 2025-10-10

Substantially Equivalent

Degen Medical

FDA 510(k) clearance K252737 for DeGen Medical Latitude-C AM Cervical Interbody Fusion System, Substantially Equivalent on 2025-10-10. Applicant: Degen Medical. Device class: 2.

Clearance details

Applicant: Degen Medical
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-08-28
Decision date: 2025-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florence, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Degen Medical

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K251829 — DeGen Medical Patient Specific Implant (PSI) System2025-12-08
K250667 — DeGen Medical Patient Specific Implant (PSI) System2025-04-04
K241077 — DeGen Medical Patient Specific Implant (PSI) System2024-10-29
K231199 — Solar Lumbar Interbody Fusion System2023-06-16
K223418 — DeGen Impulse AM System2023-03-17

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.