FDA.reportPublic FDA data

Aurora Spine

Primary DI
B521110302010
Brand
Aurora Spine
Company
AURORA SPINE, INC.
Model
PDP
Catalog number
110-302-01
Device description
CUP CURETTE, SMALL, STRAIGHT, POSTERIOR 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
OTC
false
Sterile
false
Single use
false

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
B521110302010PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5210010230Aurora SpineZIP001-0232019-06-01
B5210010240Aurora SpineZIP001-0242019-06-01
B5210010280Aurora SpineZIP001-0282019-06-01
B5210010290Aurora SpineZIP001-0292019-06-01
B5210010300Aurora SpineZIP001-0302019-06-01
B5210010310Aurora SpineZIP001-0312019-06-01
B5210010320Aurora SpineZIP001-0322019-06-01
B5210010370Aurora SpineZIP001-0372019-06-01
B5210013030Aurora SpineZIP001-3032019-06-01
B52111036110SiLO TFX MIS Sacroiliac Joint Fixation System110-361-12024-08-13
B52111036420SiLO TFX MIS Sacroiliac Joint Fixation System110-364-22024-08-13
B5211107120SiLO TFX MIS Sacroiliac Joint Fixation System110-7122024-08-13
B5211107130Apollo Anterior Cervical Plate System110-7132024-08-13
B521114001240SiLO TFX MIS Sacroiliac Joint Fixation System114-001-242024-08-13
B52111400445200SiLO TFX MIS Sacroiliac Joint Fixation System114-004-45202024-08-13
B52111400445260SiLO TFX MIS Sacroiliac Joint Fixation System114-005-45262024-08-13
B521114300010SiLO TFX MIS Sacroiliac Joint Fixation System114-300-012024-08-13
B521114301010SiLO TFX MIS Sacroiliac Joint Fixation System114-301-012024-08-13
B52111430301240SiLO TFX MIS Sacroiliac Joint Fixation System114-303-01242024-08-13
B5211143090SiLO TFX MIS Sacroiliac Joint Fixation System114-3092024-08-13

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Primary DI, Brand, Company table
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