FDA.reportPublic FDA data

Aurora Spine

Primary DI
B521110312020
Brand
Aurora Spine
Company
AURORA SPINE, INC.
Model
ADP
Catalog number
110-312-02
Device description
KERRISON RONGEUR, LARGE, STRAIGHT, ANTERIOR DISK PREP
Published
2019-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B521110312020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760.424.2004info@auroraspine.us

Regulatory Flags#

DUNS number
079119091
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B521115001100Apollo Anterior Cervical Plate System115-001-102024-08-13
B521115001120Apollo Anterior Cervical Plate System115-001-122024-08-13
B521115001140Apollo Anterior Cervical Plate System115-001-142024-08-13
B521115001160Apollo Anterior Cervical Plate System115-001-162024-08-13
B521115001180Apollo Anterior Cervical Plate System115-001-182024-08-13
B521115001200Apollo Anterior Cervical Plate System115-001-202024-08-13
B521115001220Apollo Anterior Cervical Plate System115-001-222024-08-13
B521115001240Apollo Anterior Cervical Plate System115-001-242024-08-13
B521115001260Apollo Anterior Cervical Plate System115-001-262024-08-13
B521115002260Apollo Anterior Cervical Plate System115-002-262024-08-13
B521115002280Apollo Anterior Cervical Plate System115-002-282024-08-13
B521115002300Apollo Anterior Cervical Plate System115-002-302024-08-13
B521115002320Apollo Anterior Cervical Plate System115-002-322024-08-13
B521115002340Apollo Anterior Cervical Plate System115-002-342024-08-13
B521115002360Apollo Anterior Cervical Plate System115-002-362024-08-13
B521115002380Apollo Anterior Cervical Plate System115-002-382024-08-13
B521115002400Apollo Anterior Cervical Plate System115-002-402024-08-13
B521115002420Apollo Anterior Cervical Plate System115-002-422024-08-13
B521115003390Apollo Anterior Cervical Plate System115-003-392024-08-13
B521115003420Apollo Anterior Cervical Plate System115-003-422024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261998O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262018O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262049O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262056O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262070O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262087O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262094O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262100CENTAURStryker CorporationLXH2019-11-25
07613327262285XIAStryker CorporationLXH2019-11-25
07613327263176XIA IIStryker CorporationLXH2019-11-25
07613327263183XIA IIStryker CorporationLXH2019-11-25
07613327263190XIA IIStryker CorporationLXH2019-11-25
07613327263220XIA IIStryker CorporationLXH2019-11-25