FDA.reportPublic FDA data

Mediox

Primary DI
00850054612199
Brand
Mediox
Company
Mediox Medical Service Ltd
Model
FA08409
Device description
Mediox medical, Kyphoplasty Tool Kit,include guide wire,drill,bone cement filler ,puncture needle and cannula,dilator and working cannula.Model FA08409 Product content is Puncture needle 3.7
Published
2023-08-17
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
00850054612199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054612199008500546121998500546121990850054612199

GMDN Terms#

Term, Definition table
TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118843955
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
00850054612342MedioxLengthing adult type (XL)2023-08-24
00850054612359MedioxStandard adult type (L)2023-08-24
00850054612366MedioxLengthening children type (M)2023-08-24
00850054612373MedioxStandard Children type (s)2023-08-24
00850054612380MedioxInfant typee2023-08-24
00850054612397MedioxLengthing adult type (XL)2023-08-24
00850054612403MedioxStandard adult type (L)2023-08-24
00850054612410MedioxLengthening children type (M)2023-08-24
00850054612427MedioxStandard Children type (s)2023-08-24
00850054612434MedioxInfant typee2023-08-24
00850054612441MedioxLengthing adult type (XL)2023-08-24
00850054612458MedioxStandard adult type (L) 2023-08-24
00850054612465MedioxLengthening children type (M)2023-08-24
00850054612472MedioxStandard Children type (s)2023-08-24
00850054612489MedioxInfant typee2023-08-24
00850054612496MedioxAdult2023-08-24
00850054612502MedioxChild2023-08-24
00850054612519Medioxlnfant2023-08-24
00850054612526MedioxAdult2023-08-24
00850054612533MedioxChild2023-08-24

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
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
08058964725448V-AccessG21 SRLOCJ2024-10-10
08058964727725Keyfix direct access needle 8GG21 SRLOCJ2024-10-10