FDA.reportPublic FDA data

PROVIEW

Primary DI
18257200066285
Brand
PROVIEW
Company
ORTHOFIX INC.
Model
70-2210
Device description
TUBULAR RETRACTOR 21X10 STRAIGHT MIS TUBULAR RETRACTOR
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200066285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720006628518257200066285

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
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00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
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00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
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00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
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00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23