FDA.reportPublic FDA data

DIAM™ Spinal Stabilization System

Primary DI
03701521300385
Brand
DIAM™ Spinal Stabilization System
Company
COMPANION SPINE FRANCE
Model
DIAM, Spinal Stabilization System Crimps
Catalog number
CS001A0015
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NQOProsthesis, Spinous Process Spacer/Plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQOProsthesis, Spinous Process Spacer/PlateUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240043000DIAM­™ Spinal Stabilization SystemCompanion Spine France Sas2025-12-10NQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701521300385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701521300385037015213003853701521300385

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar decompression interspinous spacerA device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275237939
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
03701521300163Companion Spine DIAM™ InstrumentationDIAM™ Spinal Stabilization System, Upper InstrumenCS001C00342026-01-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701521300347DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300354DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300361DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300378DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
04260636678998coflex instrument loaner setParadigm Spine GmbHNQO2023-03-31
00884662000529Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2020-09-28
00088466000529Superion Indirect Decompression SystemVERTIFLEX, INC.NQO2019-02-04
00884662000536Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000543Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000550Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000567Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
04260148897825coflex crimping pliers, longParadigm Spine GmbHNQO2018-10-23
04260148897849coflex dual pliersParadigm Spine GmbHNQO2018-10-10
04260148897856coflex MalletParadigm Spine GmbHNQO2018-08-02
04260148897863coflex mallet capParadigm Spine GmbHNQO2018-08-02
04260148897740coflex trial with guide and x-ray marker, 8mmParadigm Spine GmbHNQO2018-06-28
04260148897757coflex trial with guide and x-ray marker, 10mmParadigm Spine GmbHNQO2018-06-28
04260148897764coflex trial with guide and x-ray marker, 12mmParadigm Spine GmbHNQO2018-06-28
04260148897771coflex trial with guide and x-ray marker, 14mmParadigm Spine GmbHNQO2018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmParadigm Spine GmbHNQO2018-06-28
04260148897795coflex trial slider with wingsParadigm Spine GmbHNQO2018-06-28
04260148897801coflex trial capParadigm Spine GmbHNQO2018-06-28
04260148897832coflex wing loosenerParadigm Spine GmbHNQO2018-06-28
04260148898594coflex freehand crimping pliersParadigm Spine GmbHNQO2018-06-28
04260148898600coflex extractor pliersParadigm Spine GmbHNQO2018-06-28
04260148898358coflex single-use instrumentsParadigm Spine GmbHNQO2018-06-14
00884662000574Superion™ SUIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000611Vertiflex™ VIPBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000123Superion DriverVERTIFLEX, INC.NQO2017-08-16
00884662000130Superion InserterVERTIFLEX, INC.NQO2017-08-16