FDA.reportPublic FDA data

SPINERY Connections

Primary DI
00860011603627
Brand
SPINERY Connections
Company
AXON SRL
Model
SP-CD
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 double connection cooling tube is for use with two bipolar RF needles with a product code of SP-CD.
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
00860011603627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011603627008600116036278600116036270860011603627

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
00860011603696SPINERY ConnectionSP-CS2024-05-31
00860011603610SPINERY NeedleSP-BI10052024-05-27
00860011603665SPINERY GeneratorSPINERY2024-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21