FDA.reportPublic FDA data

Vertebroplasty needles

Primary DI
03760177045743
Brand
Vertebroplasty needles
Company
TEKNIMED
Model
11G
Catalog number
T060411
Published
2023-09-06
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
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
03760177045743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177045743037601770457433760177045743

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body cement cannulaA sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
764746723
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
03760177044326Signature -x CementSVP/N191-14-40002026-01-23
03760177044333Signature -x CementLVP/N191-14-40012026-01-23
03760177044340Signature -x CementMVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03760177040724CEMENTEK LVT8150LVT8150LV2015-10-16
03760177041080SINPLUS S800580052015-10-16
03760177041677KYPHON ACTIVOS 10C10AC10A2015-10-16
03760177042032MectaBone-P LV03,03,00303,03,0032015-10-16
03760177042384SPINE-FIX USUS040320SUS040320S2015-10-16
03760177042872ODONCER1000-2000µm 5ccT82102052015-10-16
03760177042889ODONCER1000-2000µm 2ccT82102022015-10-16
03760177042902ODONCER100-1000µm 5ccT82101052015-10-16
03760177042919ODONCER100-1000µm 2ccT82101022015-10-16
03760177043060ZVplastyVCF-1009VCF-10092015-10-16
03760177043923COHESIONCM0300CM03002015-10-16
03760177043930VERTEFIXVBC-100VBC-1002015-10-16
03760177043954VERTEMEND66-VMD-10066-VMD-1002015-10-16
03701505801204DynamoSpinal Cement – MV11-59202026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08058964728685KeyFix Direct Access Needle Trocar and bevel tip, 13 gaugeG21 SRLOCJ2026-10-19
08056633334908ADRIA srl - Vertebroplasty NeedleADRIA SRLOCJ2026-09-24
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
08800046100380CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
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