FDA.reportPublic FDA data

MVX-PLUS

Primary DI
03760177046399
Brand
MVX-PLUS
Company
TEKNIMED
Model
MVX-P
Catalog number
MVX-P
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760177046399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177046399037601770463993760177046399

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral bone filler, non-bioabsorbableA sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
764746723
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03701505801211Dynamo Spinal Cement System Syringe MV 1.5cc11-59212026-02-02
03701505801228DynamoSpinal Cement System Syringe MV 4cc11-59222026-02-02
03701505801235DynamoSpinal Cement System Gun MV11-59232026-02-02
03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
03760177044333Signature -x Cement LVP/N191-14-40012026-01-23
03760177044340Signature -x Cement MVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03760177042698Euroscrew NGØ6 L20T720620NG2023-12-18
03760177042704Euroscrew NGØ7 L24T720724NG2023-12-18
03760177042711Euroscrew NGØ7 L30T720730NG2023-12-18
03760177042728Euroscrew NGØ8 L24T720824NG2023-12-18
03760177042735Euroscrew NGØ9 L24T720924NG2023-12-18
03760177042742Euroscrew NGØ8 L30T720830NG2023-12-18
03760177042759Euroscrew NGØ9 L30T720930NG2023-12-18
03760177042766Euroscrew NGØ10 L30T721030NG2023-12-18
03760177042773Euroscrew NGØ11 L35T721135NG2023-12-18
03760177042780Euroscrew TCP NGØ06 L20T730620NG2023-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800038029323SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03