FDA.reportPublic FDA data

Contours VPS Volar Plating System

Primary DI
18054242516392
Brand
Contours VPS Volar Plating System
Company
ORTHOFIX SRL
Model
1
Catalog number
PSC2012TCE
Device description
SCREW, DISTAL RADIUS VOLAR, M3.5 X 0.6 MICROTHREAD, 12 MM, TITANIUM
Published
2016-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101936000CONTOURS VSP III VOLAR PLATING SYSTEMOrthofix, Inc.2010-10-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054242516392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805424251639218054242516392

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015375831OrthoNext™ Platform System Software2.1ORTHONEXTSW2.12025-01-31
18059015375848OrthoNext™ Platform System Software1.1TLHEXMODULESW1.12025-01-31
18052469476444OrthoNext™ Platform System Software1.0TLHEXMODULESW2023-03-31
18052469476451OrthoNext™ Platform System Software1.0MYHEXPLANSW2023-03-31
18053340345675OrthoNext™ Platform System Software2.0ORTHONEXTSW2023-03-31
18053340345682OrthoNext™ Platform System Software1.1JPSMODULESW2023-03-31
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23

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Primary DI, Brand, Company table
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