FDA.reportPublic FDA data

Companion Spine DIAM™ Instrumentation

Primary DI
03701521300163
Brand
Companion Spine DIAM™ Instrumentation
Company
COMPANION SPINE FRANCE
Model
DIAM™ Spinal Stabilization System, Upper Instrumen
Catalog number
CS001C0034
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253118000Companion Spine DIAM™ InstrumentationCompanion Spine France2025-12-16QLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701521300163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701521300163037015213001633701521300163

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
275237939
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701521300019Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Bi-Lateral ImpaCS001B00252026-01-12
03701521300026Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Tissue ResectorCS001B00272026-01-12
03701521300033Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Tissue ResectorCS001B00282026-01-12
03701521300040Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Unilateral InseCS001B00242026-01-12
03701521300057Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, CrimperCS001B00262026-01-12
03701521300064Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, 8mm TemplateCS001B00082026-01-12
03701521300071Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, 10mm TemplateCS001B00102026-01-12
03701521300088Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, 12mm TemplateCS001B00122026-01-12
03701521300095Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, 14mm TemplateCS001B00142026-01-12
03701521300101Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Sicard Punch, SCS001B00212026-01-12
03701521300118Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Sicard Punch, LCS001B00222026-01-12
03701521300132Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Distractor, SmaCS001B00292026-01-12
03701521300149Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Outer CaseCS001C00312026-01-12
03701521300156Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Outer Case LidCS001C00322026-01-12
03701521300170Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Ratcheting T-haCS001B00302026-01-12
03701521300408Companion Spine DIAM™ InstrumentationDIAM™ spinal stabilization System, Implant InserteCS001B00312026-01-12
03701521300415Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Outer Case (altCS001C00352026-01-12
03701521300347DIAM™ Spinal Stabilization SystemDIAM, Spinal Stabilization System 08 mmCS001A00082025-12-19
03701521300354DIAM™ Spinal Stabilization SystemDIAM, Spinal Stabilization System 10 mmCS001A00102025-12-19
03701521300361DIAM™ Spinal Stabilization SystemDIAM, Spinal Stabilization System 12 mmCS001A00122025-12-19

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Primary DI, Brand, Company table
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