FDA.reportPublic FDA data

ANTERIS Thoracolumbar Plate System

Primary DI
00193082162688
Brand
ANTERIS Thoracolumbar Plate System
Company
SPINECRAFT, LLC
Model
LPS-APS50-30
Catalog number
LPS-APS50-30
Device description
ANTERIS Self-tapping Screws, dia. 5.0mm, L30mm
Published
2026-05-20
Public version status
New
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
K260015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260015000ANTERIS Thoracolumbar Plate SystemSpineCraft2026-03-04KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193082162688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082162688001930821626881930821626880193082162688

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
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
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
00193082162794ANTERIS Thoracolumbar Plate System820A-45-15820A-45-152026-05-20

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Primary DI, Brand, Company table
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00810017916498Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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