FDA.reportPublic FDA data

VENTO Fixation Screw

Primary DI
03701089514361
Brand
VENTO Fixation Screw
Company
AMPLITUDE SAS
Model
1-01-12-9150
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121297000ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd.2012-12-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701089514361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701089514361037010895143613701089514361

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, 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). There are a number of kinds available: 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 across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0033475418741regulatoryaffairs@amplitude-ortho.com

Regulatory Flags#

DUNS number
634855407
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701089501071VENTO Fixation Screw1-01-12-91452017-12-22
03701089514309VENTO Fixation Screw1-01-12-91152017-12-11
03701089514316VENTO Fixation Screw1-01-12-91202017-12-18
03701089514323VENTO Fixation Screw1-01-12-91252017-12-18
03701089514330VENTO Fixation Screw1-01-12-91302017-12-18
03701089514347VENTO Fixation Screw1-01-12-91352017-12-18
03701089514354VENTO Fixation Screw1-01-12-91402017-12-18
03701089514378VENTO Fixation Screw1-01-12-91552017-12-18
03701089514385VENTO Fixation Screw1-01-12-91602017-12-18
03701089514392VENTO Fixation Screw1-01-12-91652017-12-18
03701089514408VENTO Fixation Screw1-01-12-91702017-12-18
03701089500814AMPLITUDE1-02100301-02100302017-08-07
03701089500821AMPLITUDE1-02100331-02100332017-08-08
03701089500838AMPLITUDE1-02100361-02100362017-08-08
03701089500845AMPLITUDE1-02100391-02100392017-08-08
03701089524124Crescendo Patella Component 28x6mm 1-01-07-70012018-10-16
03701089524131Crescendo Patella Component 30x7mm1-01-07-70022018-10-16
03701089524148Crescendo Patella Component 32x8mm 1-01-07-70032018-10-16
03701089524155Crescendo Patella Component 35x9mm1-01-07-70042018-10-16
03701089502306Nifty Fifty VENTO Cup1-01-12-33512019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07611996111514POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111538POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111552POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112320POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112351POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112368POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996114638POLARCUPSmith & Nephew, Inc.LPH2015-11-25