FDA.reportPublic FDA data

Arx MIS

Primary DI
00190837144890
Brand
Arx MIS
Company
Life Spine, Inc.
Model
12-7555-03
Published
2026-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233455000ARx MIS Spinal Screw SystemLife Spine, Inc.2023-12-12NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837144890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837144890001908371448901908371448900190837144890

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

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837124137Arx17-8575-032026-04-17
00190837124144Arx17-8580-032026-04-17
00190837124151Arx17-8585-032026-04-17
00190837124168Arx17-8590-032026-04-17
00190837124175Arx17-8595-032026-04-17
00190837124243Arx17-9525-032026-04-17
00190837124250Arx17-9530-032026-04-17
00190837124267Arx17-9535-032026-04-17
00190837124274Arx17-9540-032026-04-17
00190837124281Arx17-9545-032026-04-17
00190837124298Arx17-9550-032026-04-17
00190837124304Arx17-9555-032026-04-17
00190837124311Arx17-9560-032026-04-17
00190837124397Arx17-95100-032026-04-17
00190837124403Arx17-95105-032026-04-17
00190837124410Arx17-95110-032026-04-17
00190837124427Arx17-95115-032026-04-17
00190837124434Arx17-95120-032026-04-17
00190837125912Arx17-8575-132026-04-17
00190837125929Arx17-8580-132026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613154111725OASYSStryker CorporationKWP2015-09-14
07613154129867OASYSStryker CorporationKWP2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613154170166OASYSStryker CorporationKWP2015-09-14
07613154345014MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345021MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345038MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345045MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345052MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345069MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345090MAC TITANIUMStryker CorporationKWP2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08
07613153045861XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationKWP2014-12-08
07613153045892XIA IIStryker CorporationKWP2014-12-08
07613153045908XIA IIStryker CorporationKWP2014-12-08
07613153045915XIA IIStryker CorporationKWP2014-12-08