FDA.reportPublic FDA data

AURORA SPINE, INC.

Matched from indexed company URL: Aurora Spine

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103269713010326971AURORA SPINE, INC.1Y2026-01-011930 Palomar Point Way Suite #103 Carlsbad CA US 92008
30204172983020417298Aurora Spine Manufacturing1N2026-01-013146 Tiger Run Ct, Suite 116 Carlsbad CA US 92010

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
B521115001100Apollo Anterior Cervical Plate System - Apollo Plate 1 Level 10mm760-424-2004info@auroraspine.us
B521115001120Apollo Anterior Cervical Plate System - Apollo Plate 1 Level 12mm760-424-2004info@auroraspine.us
B521115001140Apollo Anterior Cervical Plate System - Apollo Plate 1 Level 14mm760-424-2004info@auroraspine.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1647751763866196K221399ZIP™ MIS Interspinous Fusion SystemPEK2022-07-08
1647751437106975K221047SILO TFX MIS Sacroiliac Joint Fixation SystemOUR2022-10-03
1647751736592031K220610SOLO-LOVD2022-05-27
1647751490073454K210521DEXA-C Cervical Interbody SystemODP2021-08-02
1647751568505502K210325APOLLO Anterior Cervical Plate (ACP) SystemKWQ2021-03-23
1647751880568150K141317ZIP MIS INTERSPINOUS FUSION SYSTEMPEK2014-11-17
1647751781363341K140715ZIP MIS INTERSPINOUS FUSION SYSTEMPEK2014-04-17
1647751033774958K133967INTERBODY CAGE SYSTEMMAX2014-01-31
1647751509721174K133091ZIP MIS INTERSPINOUS FUSION SYSTEMPEK2013-11-27
1647751951448650K111484DISCOVERYODP2011-09-12
1647751121293462K071743PILLAR PEDICLE SCREW SYSTEMMNI2007-07-06
1647751167373524
3348381509721174
1647752040219425

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PEK42022-07-08
ODP22021-08-02
OUR12022-10-03
OVD12022-05-27
KWQ12021-03-23
MAX12014-01-31
MNI12007-07-06

PMN#

SOLO-L

2022-05-27

Aurora Spine Inc

GUDID#

80 records. Showing 1-40. Next