DeviceClearance

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

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.

Summary

HC Biologics' record names three HC BIOLOGICS OSTEOPOINT cage lines: PEEK CAGES, CERVICAL PEEK CAGES, and LUMBAR PEEK CAGES. All are filed under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

HC Biologics filed from Miami, Florida. The record shows 70 calendar days from receipt to decision (February 2 to April 13, 2026).

Clearance details

Applicant
HC Biologics, LLC
Product code
Product code ODP
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ODP

product code ODP
Injury
310
Total
310

Source: openFDA MAUDE database, through . 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.