FDA.reportPublic FDA data

ASTRA Spine System

Primary DI
00193082156458
Brand
ASTRA Spine System
Company
SPINECRAFT, LLC
Model
A6H-L65R
Catalog number
A6H-L65R
Device description
ASTRA Laminar Reduction Hook, Throat 6.5mm
Published
2023-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223273000ASTRA Spine SystemSpinecraft, LLC2022-12-22NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193082156458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082156458001930821564581930821564580193082156458

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(630)920-7300info@spinecraft.com

Regulatory Flags#

DUNS number
783908713
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193082162084ANTERIS Thoracolumbar Plate SystemLPS-APSD-10LPS-APSD-102026-05-20
00193082162091ANTERIS Thoracolumbar Plate SystemLPS-APSD-12LPS-APSD-122026-05-20
00193082162107ANTERIS Thoracolumbar Plate SystemLPS-APSD-14LPS-APSD-142026-05-20
00193082162114ANTERIS Thoracolumbar Plate SystemLPS-APSD-16LPS-APSD-162026-05-20
00193082162121ANTERIS Thoracolumbar Plate SystemLPS-APSD-18LPS-APSD-182026-05-20
00193082162138ANTERIS Thoracolumbar Plate SystemLPS-APSD-20LPS-APSD-202026-05-20
00193082162145ANTERIS Thoracolumbar Plate SystemLPS-APSD-22LPS-APSD-222026-05-20
00193082162152ANTERIS Thoracolumbar Plate SystemLPS-APSD-24LPS-APSD-242026-05-20
00193082162169ANTERIS Thoracolumbar Plate SystemLPS-APSL-10LPS-APSL-102026-05-20
00193082162176ANTERIS Thoracolumbar Plate SystemLPS-APSL-12LPS-APSL-122026-05-20
00193082162183ANTERIS Thoracolumbar Plate SystemLPS-APSL-14LPS-APSL-142026-05-20
00193082162190ANTERIS Thoracolumbar Plate SystemLPS-APSL-16LPS-APSL-162026-05-20
00193082162206ANTERIS Thoracolumbar Plate SystemLPS-APSL-18LPS-APSL-182026-05-20
00193082162213ANTERIS Thoracolumbar Plate SystemLPS-APSL-20LPS-APSL-202026-05-20
00193082162220ANTERIS Thoracolumbar Plate SystemLPS-APSL-22LPS-APSL-222026-05-20
00193082162237ANTERIS Thoracolumbar Plate SystemLPS-APSL-24LPS-APSL-242026-05-20
00193082162688ANTERIS Thoracolumbar Plate SystemLPS-APS50-30LPS-APS50-302026-05-20
00193082162695ANTERIS Thoracolumbar Plate SystemLPS-APS55-30LPS-APS55-302026-05-20
00193082162701ANTERIS Thoracolumbar Plate SystemLPS-APS50-20LPS-APS50-202026-05-20
00193082162718ANTERIS Thoracolumbar Plate SystemLPS-APS55-20LPS-APS55-202026-05-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
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00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
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00840354203692Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
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00840354203784Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203791Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
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00840354203814Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203821Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203838Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203845Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203852Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
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00840354203876Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
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00840354203906Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
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00840354203920Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06