HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES— 510(k) K260340

Name: FDA 510(k) clearance K260340
Creator: U.S. Food and Drug Administration
Published: 2026-04-13

Substantially Equivalent

HC Biologics, LLC

FDA 510(k) clearance K260340 for HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES, Substantially Equivalent on 2026-04-13. Applicant: HC Biologics, LLC. Device class: 2.

Clearance details

Applicant: HC Biologics, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-02-02
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

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K250092 — HC Biologics Osteopoint Spinal Fixation System2025-03-27

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.