Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010326971

FEI Number

3010326971

Entity Name

AURORA SPINE, INC.

City/State/Country

Carlsbad, CA, US

Establishment Address

1930 Palomar Point Way, Suite #103, Carlsbad, CA 92008, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Aurora Spine (Owner Number: 10045511)

Owner / Operator Contact Address

1930 Palomar Point Way, Ste 103, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210325

PMA Number

N/A

All Registered Proprietary Names

Surgical Trays SiLO TFX MIS Sacroiliac Fusion System DISCOVERY MIS Interbody Fusion System ECHO XL MIS Interbody Fusion System VOX MIS Interbody Fusion System EOS MIS Interbody Fusion System AFFINITY MIS Interbody Fusion System DISCOVERY MIS Interbody Fusion System ECHO MIS Interbody Fusion System ZIP MIS Interspinous Fusion System ZIP ULTRA MIS Interspinous Fusion System ZIP LP MIS Interspinous Fusion System ZIP 51 MIS Interspinous Fusion System ZIP 51 ULTRA MIS Interspinous Fusion System ZIP MIS Interlaminar Fusion System ZIP MIS Interspinous Fusion System ZIP ULTRA MIS Interspinous Fusion System SILO TFX DEXA-C Cervical Interbody System APOLLO Anterior Cervical Plate (ACP) System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-12-10
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2021-11-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2021-11-01
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2022-11-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-11-25
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-10-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-12-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-12-31
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-12-31
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-12-31
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2022-11-15
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2013-12-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-11-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-11-01

Official Correspondent

Laszlo Garamszegi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aurora Spine

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020417298	Aurora Spine Manufacturing	Carlsbad, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010326971. Last updated year: 2026. Please use registration number 3010326971 when referencing this establishment in official correspondence.