FDA.reportPublic FDA data

PROVIEW

Primary DI
18257200066650
Brand
PROVIEW
Company
ORTHOFIX INC.
Model
70-3218
Device description
PARALLEL COMPRESSOR PERCUTANEOUS ICON
Published
2019-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWNINSTRUMENT, COMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200066650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720006665018257200066650

GMDN Terms#

Term, Definition table
TermDefinition
Growth-correction orthopaedic fixation plate kitA collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200068166PILLAR XL72-19092019-03-19
18257200081387CONSTRUX - PEEK VBR450217-000148-00102020-02-03
18257200131969PEMF - PHYSIO-STIM655302-000153022020-01-16
18257200131976PEMF - PHYSIO-STIM655303-000153032020-01-16
18257200131983PEMF - PHYSIO-STIM655313-000153132020-01-16
18257200131990PEMF - PHYSIO-STIM655314-00015314L2020-01-16
18257200132003PEMF - PHYSIO-STIM655314-01015314R2020-01-16
18257200132010PEMF - PHYSIO-STIM655315-000153152020-01-16
18257200022151FORZA87-1209SP2019-09-24
18257200022168FORZA87-1210SP2019-09-24
18257200022175FORZA87-1211SP2019-09-24
18257200022182FORZA87-1212SP2019-09-24
18257200022199FORZA87-1213SP2019-09-24
18257200022205FORZA87-1214SP2019-09-24
18257200022212FORZA87-1215SP2019-09-24
18257200022229FORZA87-1216SP2019-09-24
18257200022236FORZA87-1308SP2019-09-24
18257200022243FORZA87-1309SP2019-09-24
18257200022250FORZA87-1310SP2019-09-24
18257200022267FORZA87-1311SP2019-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B922F005003608ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWN2026-03-11
G079C5080000140MIS Golden Isles Pedicle Screw System Intelivation, LLCHWN2026-01-30
00199150061983Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2026-01-15
00888480530817Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
03662663217040Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
00840180543733General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
00840180544037General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
03662663244718Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-18
03662663198196Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-17
00840124525061Metalogix RevolutionFUSION ORTHOPEDICS, LLCHWN2025-12-16
03662663162326Zyston Interbody Spacer SystemHighridge Medical, LLCHWN2025-12-16
03662663195850Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195867Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195928Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195935Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195942Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195959Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195966Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195973Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195980Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196000Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196017Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663198189Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
00888480484912Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484929Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484936Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663113199Virage OCT Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663125895Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663136884Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03
03662663136891Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03