NeoFuse Ti3D PLIF/TLIF/Cervical Interbody— 510(k) K170318

Substantially Equivalent

Ht Medical, LLC

FDA 510(k) clearance K170318 for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, Substantially Equivalent on 2017-07-12. Applicant: Ht Medical, LLC.

Clearance details

Applicant: Ht Medical, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2017-02-01
Decision date: 2017-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

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.