FDA.reportPublic FDA data

PROVIEW

Primary DI
18257200066667
Brand
PROVIEW
Company
Orthofix US LLC
Model
70-3219
Device description
DISTRACTOR BODY PERCUTANEOUS MIS
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWBEXTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200066667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720006666718257200066667

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
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200028177PHOENIX SFS20-01012026-07-17
18257200028207PHOENIX SFS20-01202026-07-17
18257200028917FIREBIRD SFS201130732026-07-17
18257200028924FIREBIRD SFS201130742026-07-17
18257200028931FIREBIRD SFS201130752026-07-17
18257200028948FIREBIRD SFS201130762026-07-17
18257200028955FIREBIRD SFS201130782026-07-17
18257200028979FIREBIRD SFS201130802026-07-17
18257200028986FIREBIRD SFS201130812026-07-17
18257200028993FIREBIRD SFS201130822026-07-17
18257200029006FIREBIRD SFS201130832026-07-17
18257200029013FIREBIRD SFS201130842026-07-17
18257200029020FIREBIRD SFS201130852026-07-17
18257200029280FIREBIRD SFS201147972026-07-17
18257200029846FIREBIRD SFS301100252026-07-17
18257200029853FIREBIRD SFS301100262026-07-17
18257200029860FIREBIRD SFS301100272026-07-17
18257200029877FIREBIRD SFS301100282026-07-17
18257200029884FIREBIRD SFS301100292026-07-17
18257200029945FIREBIRD SFS301100352026-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017915804SABER-XA, Height ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915811SABER-XA, Lordosis ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915958Slap HammerELEVATION SPINE, INC.HWB2026-08-14
00810017915965Slap Hammer AdaptorELEVATION SPINE, INC.HWB2026-08-14
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
08800068946966BENCOXCorentec Co., LtdHWB2026-07-01
08800068946973BENCOXCorentec Co., LtdHWB2026-07-01
08800068963666BENCOXCorentec Co., LtdHWB2026-07-01
08806373897344BENCOXCorentec Co., LtdHWB2026-07-01
08806373897351BENCOXCorentec Co., LtdHWB2026-07-01
08806373897368BENCOXCorentec Co., LtdHWB2026-07-01
08806373897375BENCOXCorentec Co., LtdHWB2026-07-01
08806373897382BENCOXCorentec Co., LtdHWB2026-07-01
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00885556820964General InstrumentsSmith & Nephew, Inc.HWB2023-10-27
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10