Chrysalis Intelligence · Sponsors · Astura Medical

Astura Medical

Irving, TX, US · 15 510(k) clearances

Total clearances
15
2020-04-02 → 2026-01-22
Last 12 months
2
Product codes
9
Most recent
2026-01-22
Name variants in FDA filings: Astura Medical, LLC / Astura Medical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 3 2025-10-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 3 2023-05-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 3 2023-01-19
PML Bone Cement, Posterior Screw Augmentation Class II Orthopedic 1 2026-01-22
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2024-10-17
MQP Spinal Vertebral Body Replacement Device Class II Orthopedic 1 2024-03-08
OUR Sacroiliac Joint Fixation Class II Orthopedic 1 2023-10-24
OWI Bone Fixation Cerclage, Sublaminar Class II Orthopedic 1 2023-05-04
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Class II Orthopedic 1 2020-10-26
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2026-01-22 K252885 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System PML Class II Orthopedic
2025-10-21 K252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System NKB Class II Orthopedic
2025-01-07 K243259 MASADA Modular Spinal Fixation System NKB Class II Orthopedic
2024-10-17 K240160 EGPS Navigated Instruments OLO Class II Neurology
2024-03-08 K233359 DOMINION Expandable Corpectomy System MQP Class II Orthopedic
2023-11-16 K231694 MASADA Modular Spinal Fixation System NKB Class II Orthopedic
2023-10-24 K232211 REUNION Sacroiliac Joint Fusion System OUR Class II Orthopedic
2023-05-09 K223335 SIRION Lateral Lumbar Interbody System MAX Class II Orthopedic
2023-05-04 K222097 OLYMPIC Deformity Band System OWI Class II Orthopedic
2023-01-19 K222554 EL CAPITAN Anterior Lumbar Interbody Fusion OVD Class II Orthopedic
2022-03-30 K214047 EL CAPITAN Anterior Lumbar Interbody Fusion System OVD Class II Orthopedic
2021-01-06 K202495 SIRION Lateral Lumbar Interbody Fusion MAX Class II Orthopedic
2020-10-26 K202065 DOLOMITE Anterior Cervical Stabilization System OVE Class II Orthopedic
2020-04-21 K192492 EL CAPITAN Anterior Lumber Interbody System OVD Class II Orthopedic
2020-04-02 K192006 SIRION Lateral Lumbar Interbody System MAX Class II Orthopedic