HC Biologics Osteopoint Spinal Fixation System— 510(k) K250092

Name: FDA 510(k) clearance K250092
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

Substantially Equivalent

HC Biologics, LLC

FDA 510(k) clearance K250092 for HC Biologics Osteopoint Spinal Fixation System, Substantially Equivalent on 2025-03-27. Applicant: HC Biologics, LLC. Device class: 2.

Clearance details

Applicant: HC Biologics, LLC
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2025-01-14
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

view all

K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
K252139 — Kentrospine Viktr-MIS® Pedicle screw system2026-09-27

More clearances from HC Biologics, LLC

view all

K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES2026-04-13

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.