FDA.reportPublic FDA data

Astura Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30159416383011764740Astura Medical1N2026-01-014949 W Royal Ln Irving TX US 75063

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840085201585SIRION - RETRACTOR DRIVER760-814-8047troy@asturamedical.com
00840085213120SIRION - LLIF IMPLANT TRIAL, MODULAR, ANGLED RIGHT7608148047PARKER@ASTURAMEDICAL.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2357081953578558K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML2026-01-22
2357081444650670K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemNKB2025-10-21
2357081490540978K243259MASADA Modular Spinal Fixation SystemNKB2025-01-07
2357081545917183K240160EGPS Navigated InstrumentsOLO2024-10-17
2357081103902960K233359DOMINION Expandable Corpectomy SystemMQP2024-03-08
2357081410711607K232211REUNION Sacroiliac Joint Fusion SystemOUR2023-10-24
2357081246041849K231694MASADA Modular Spinal Fixation SystemNKB2023-11-16
2357081582941620K223335SIRION Lateral Lumbar Interbody SystemMAX2023-05-09
2357081361964761K222554EL CAPITAN Anterior Lumbar Interbody FusionOVD2023-01-19
2357081788151925K222097OLYMPIC Deformity Band SystemOWI2023-05-04
2357082057474105K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemOVD2022-03-30
2357081811752072K202495SIRION Lateral Lumbar Interbody FusionMAX2021-01-06
2357081174565181K202065DOLOMITE Anterior Cervical Stabilization SystemOVE2020-10-26
2357081432254258K192492EL CAPITAN Anterior Lumber Interbody SystemOVD2020-04-21
2357081167458836K192006SIRION Lateral Lumbar Interbody SystemMAX2020-04-02
2357081859930177K190426ALTA Anterior Cervical Corpectomy SystemPLR2019-10-24
2357081536686482K182982BridalVeil Navigated InstrumentsOLO2019-01-04
2357081405411147K182877HALF DOME Posterior Lumbar Interbody SystemMAX2019-05-03
2357081863972962K182239OLYMPIC Posterior Spinal Fixation SystemNKB2018-10-18
2357081998569602K181139OLYMPIC Posterior Spinal Fixation SystemNKB2018-07-06
2357081446639315K173324ALTA Anterior Cervical Interbody SpacerODP2018-02-27
2357081256223834K172947HALF DOME Posterior Lumbar Interbody SystemMAX2018-04-18
2357081483448538K172166OLYMPIC Navigated InstrumentsOLO2018-04-27
2357081980086514K171250BRIDALVEIL Occipital Cervical Thoracic SystemNKG2017-10-02
2357081149302519K163481HALF DOME Posterior Lumbar Interbody SystemMAX2017-05-03
2357081741558647K160702ZION Anterior Cervical Fixation SystemKWQ2016-08-23
2357081929653142K160154ALTA Anterior Cervical Interbody SpacerODP2016-05-13
2357081596148293K153446OLYMPIC Posterior Spinal Fixation SystemOSH2016-04-08
2357082014659573K152512Half Dome Posterior Lumbar Interbody SystemMAX2016-01-28
2357081568555771
2357081678771600

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX72023-05-09
NKB52025-10-21
OLO32024-10-17
OVD32023-01-19
ODP22018-02-27
PML12026-01-22
MQP12024-03-08
OUR12023-10-24
OWI12023-05-04
OVE12020-10-26
PLR12019-10-24
NKG12017-10-02
KWQ12016-08-23
OSH12016-04-08

PMN#

GUDID#

200 records. Showing 1-40. Next