FDA.reportPublic FDA data

Aurora Spine

Primary DI
B5211053250110
Brand
Aurora Spine
Company
AURORA SPINE, INC.
Model
DISCOVERY
Catalog number
105-325-011
Device description
DISCOVERY, TRIAL-P, 15mm x 18mm, 11mm
Published
2019-04-01
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111484000DISCOVERYIntuitive Spine, LLC2011-09-12ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5211053250110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11Millimeter
Length15Millimeter
Width18Millimeter

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
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
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00889929072936HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
G079100120705S1Advantage C Cervical Interbody Fusion DeviceIntelivation, LLCODP2026-07-24
G079100140705S1Advantage C Cervical Interbody Fusion DeviceIntelivation, LLCODP2026-07-24
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22