neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical— 510(k) K222988

Substantially Equivalent

Ht Medical D.B.A. Xenix Medical

FDA 510(k) clearance K222988 for neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical, Substantially Equivalent on 2023-09-01. Applicant: Ht Medical D.B.A. Xenix Medical.

Clearance details

Applicant: Ht Medical D.B.A. Xenix Medical
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2022-09-28
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.