FDA.report

Arx MIS

Primary DI
00190837170103
Brand
Arx MIS
Company
Life Spine, Inc.
Model
13602-080
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions

SubmissionSupplement
K233455000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190837170103PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
183641617
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190837124458Arx17-10525-032026-03-23
00190837124465Arx17-10530-032026-03-23
00190837124472Arx17-10535-032026-03-23
00190837124489Arx17-10540-032026-03-23
00190837124496Arx17-10545-032026-03-23
00190837124502Arx17-10550-032026-03-23
00190837124519Arx17-10555-032026-03-23
00190837124526Arx17-10560-032026-03-23
00190837124533Arx17-10565-032026-03-23
00190837124540Arx17-10570-032026-03-23
00190837124557Arx17-10575-032026-03-23
00190837124564Arx17-10580-032026-03-23
00190837124571Arx17-10585-032026-03-23
00190837124588Arx17-10590-032026-03-23
00190837124595Arx17-10595-032026-03-23
00190837124618Arx17-105105-032026-03-23
00190837124625Arx17-105110-032026-03-23
00190837124632Arx17-105115-032026-03-23
00190837124649Arx17-105120-032026-03-23
00190837124656Arx17-105125-032026-03-23

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