FDA.reportPublic FDA data

CAPO Needle

Primary DI
08800046100380
Brand
CAPO Needle
Company
NEXONE BIO CO., LTD.
Model
NOB-VPU11SB
Published
2024-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046100380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046100380088000461003808800046100380

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693705461
Device count
1
Premarket exempt
true
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
08800046101080CAPO NeedleNOR-VPNL11SB2024-10-29
08800046101202CAPO NeedleNOB-VPNL10D2024-10-29
08800046100427CAPO NeedleNOB-VPU11D2024-05-08
08800046101066CAPO NeedleNOR-OSK095D2024-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOCJ2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOCJ2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOCJ2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOCJ2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOCJ2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOCJ2025-12-17
08033860046613BIOPSYBELLBIOPSYBELL SRLOCJ2025-10-27
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OCJ2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OCJ2025-10-23
08809281659806TVP System (Vertebra Plasty SET B)Taeyeon Medical co.,Ltd.OCJ2025-09-03
08809281659417PCD SystemTaeyeon Medical co.,Ltd.OCJ2025-08-22
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVIzi Medical Products, LLCOCJ2025-05-21
B90829211908Main-AXS Needle-RetropsoasMainstream Medical Devices, LLCOCJ2025-04-30
08053175016125Vertebroplasty NeedleADRIA SRLOCJ2025-04-07
B908350008000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
B908350009000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
08800046101080CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08800046101202CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08058964724687V-AccessG21 SRLOCJ2024-10-16
08058964725356V-AccessG21 SRLOCJ2024-10-16
08058964725363V-AccessG21 SRLOCJ2024-10-16
08058964725417V-AccessG21 SRLOCJ2024-10-16
08058964724021KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964724052KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724083KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724113KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964725431V-AccessG21 SRLOCJ2024-10-10
08058964725448V-AccessG21 SRLOCJ2024-10-10
08058964727725Keyfix direct access needle 8GG21 SRLOCJ2024-10-10
08058964727732Keyfix Bone Cement Filler Cannula 9GG21 SRLOCJ2024-10-10