FDA.reportPublic FDA data

SPINERY Connection

Primary DI
00860011603696
Brand
SPINERY Connection
Company
AXON SRL
Model
SP-CS
Device description
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The single connection cooling tube is for use with one bipolar RF needle with a product code of SP-CS.
Published
2024-05-31
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223303000Spinery™ RF Ablation SystemAxon Spine Medical System2023-08-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011603696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011603696008600116036968600116036960860011603696

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe cooling tubing setA collection of flexible tubing and associated items that may include clamps, filters, and connectors, intended to be used with a peristaltic pump to deliver closed-loop circulation of a cooling solution (e.g., saline, sterile water) to a percutaneous radio-frequency ablation probe at a specified flow rate during a percutaneous ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
439154305
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
00860011603603SPINERY NeedleSP-BI07042024-05-31
00860011603627SPINERY ConnectionsSP-CD2024-05-31
00860011603610SPINERY NeedleSP-BI10052024-05-27
00860011603665SPINERY GeneratorSPINERY2024-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693362MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693379MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693454MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693461MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693478MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693485MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10