FDA.reportPublic FDA data

ALLTUM

Primary DI
00193082000522
Brand
ALLTUM
Company
SPINECRAFT, LLC
Model
VS1-4018
Catalog number
VS1-4018
Device description
ALLTUM ACP Screw - Variable, DIA.4 L18mm
Published
2019-02-15
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
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103505000ALTUM ANTERIOR CERVICAL PLATESpinecraft, LLC2011-03-15KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193082000522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082000522001930820005221930820005220193082000522

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
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00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
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