FDA.reportPublic FDA data

ASTRA-OCT Spine System

Primary DI
M824A3R35070K1
Brand
ASTRA-OCT Spine System
Company
SPINECRAFT, LLC
Model
A3R-35-070K
Catalog number
A3R-35-070K
Device description
ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 70mm
Published
2018-10-03
Public version status
Update
Distribution status
Not 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
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181350000ASTRA-OCT Spine SystemSpinecraft, LLC2018-07-06NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M824A3R35070K1PrimaryHIBCC0
00193082082320SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082082320001930820823201930820823200193082082320

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-1112info@device.com
+1(630)920-7300info@spinecraft.com

Regulatory Flags#

DUNS number
783908713
Device count
1
DM exempt
true
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
00193082164828ORIO-3D Cage System820A-210820A-2102026-07-30
00193082167416ORIO-3D Cage System820C-210-2820C-210-22026-07-30
00193082167430ORIO-3D Cage System820A-200820A-2002026-07-30
00193082167447ORIO-3D Cage System820A-100820A-1002026-07-30
00193082167454ORIO-3D Cage System820A-210-1820A-210-12026-07-30
00193082167461ORIO-3D Cage System820A-210-2820A-210-22026-07-30
00193082167478ORIO-3D Cage System820A-210-3820A-210-32026-07-30
00193082167492ANTERIS Thoracolumbar Plate System820A-310820A-3102026-07-30
00193082167508ANTERIS Thoracolumbar Plate System820A-310-1820A-310-12026-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194075Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194082Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194099Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194105Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194112Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194129Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194136Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194143Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194150Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194167Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194174Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194181Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194198Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194204Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
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00840606194228Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
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00840606194242Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30