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510(k) Data Aggregation
K Number
K223303Device Name
Spinery RF Ablation System
Manufacturer
Date Cleared
2023-08-30
(307 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Axon Spine Medical System
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spinery™ RF Ablation System is intended for:
Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
Device Description
Spinery™ RF Ablation System is an active medical device, intended for radiofrequency thermal ablation of spine metastation tumors.
It is a surgically invasive device intended for transient use, as the catheter percutaneously the human body in the target bone through a surgical incision, aided by other access kit), and remains in the body for the treatment time, estimated in about 20 minutes as a maximum time length.
It is an active therapeutic device because it is intended to provide treatment and pain alleviation of the human bone.
It is not intended to be used on the central nervous system.
The Spinery™ RF Ablation System includes the following components:
1. SpineryTM Radiofrequency Generator (REF: SPINERY)
a. Peristaltic Pump
2. Spinery™ Needles:
a. Bipolar cooled needle with electrodes length of 7 mm and intra-electrodes length of 4 mm (REF: SP-B10704)
b. Bipolar cooled needle with electrodes length of 10 mm and intra-electrodes length of 5 mm (REF: SP-B11005)
3. Spinery™ Connections
a. Cooling system connection pipe for double needle approach (REF: SP-CD)
b. Cooling system connection pipe for single needle approach (REF: SP-CS)
4. Manual Infusion System
5. Bone Access Kit
a. The SP-BI0704 needle has the access kit with code AXONKIT-22
b. The SP-BI1005 needle has the access kit with code AXONKIT-29
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