FDA.reportPublic FDA data

DISCOVERY TiNano ACIF

Primary DI
B521105010507
Brand
DISCOVERY TiNano ACIF
Company
AURORA SPINE, INC.
Model
105010507
Catalog number
105010507
Device description
DISCOVERY TiNano ACIF14mm X 16mm X 5 X 7
Published
2017-02-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
B521105010507PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation feedback device, manualA portable, manually-operated device intended to be applied to the chest of a patient experiencing cardiac arrest to assist a person trained in cardiopulmonary resuscitation (CPR) to deliver effective manual chest compressions. It typically consists of a chest plate with a large depressible button and is intended to translate an applied downward force into a well-positioned chest compression whilst indicating (e.g., with a click) when optimum force has been applied/removed; it may also assist the timing of chest compressions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Height7Millimeter
Length14Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
079119091
Device count
1
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
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00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
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