FDA.reportPublic FDA data

Keyfix direct access needle 8G

Primary DI
08058964727725
Brand
Keyfix direct access needle 8G
Company
G21 SRL
Model
900205
Published
2024-10-10
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
08058964727725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058964727725080589647277258058964727725

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
431529195
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058964720122G3A 40 Bone Cement8000092019-03-08
08058964720245V-FAST8000368000362017-03-29
08058964723819V-STEADY8000398000392017-03-29
08058964726759OrthoSteady G8000198000192018-05-03
08058964729033Arthrex Bone Cement HVAS-901-HV2024-10-04
08058964729040Arthrex Bone Cement MVAS-901-MV2024-10-04
08058964728647Arthrex Bone Cement HVAR-901-HV2024-09-16
08058964728678BRAVO HV611-01-0402024-09-16
08058964728722Arthrex Bone Cement HV w/GAR-901-HVG2024-09-16
08058964728739Arthrex Bone Cement MVAR-901-MV2024-09-16
08058964728746Arthrex Bone Cement MV w/GAR-901-MVG2024-09-16
08058964729002BRAVO MV610-01-0402024-09-16
08058964729019BRAVO MV+G610-01-1402024-09-16
08058964729026BRAVO HV+G611-01-1402024-09-16
08058964720047G3 40 Radiopaque Bone Cement8000042020-04-01
08058964723970G1 40 Radiopaque Bone Cement8000022020-04-01
08058964728685KeyFix Direct Access Needle Trocar and bevel tip, 13 gauge9001062026-10-19
08058964729767Easy Winch 13 G, 15 mm9002222026-10-19
08058964729774Easy Winch 13 G, 10 mm9002212026-10-19
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mm9000259000252026-09-30

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