Arx

Primary DI
00190837151454
Brand
Arx
Company
Life Spine, Inc.
Model
NC355-105-5
Published
2026-02-25
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220341000ARx Modular Spinal SystemLife Spine, Inc.2022-05-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837151454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837151454001908371514541908371514540190837151454

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
B678520297S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520485S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520486S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520487S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520488S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520489S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520490S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520491S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520492S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520493S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520494S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520495S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520496S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02