FDA.reportPublic FDA data

SKYLON Stem

Primary DI
03701089520522
Brand
SKYLON Stem
Company
AMPLITUDE SAS
Model
1-01-19-0801
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
K133370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133370000REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CESignature Orthopaedics Pty Limited2014-07-22LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701089520522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701089520522037010895205223701089520522

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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
03701089514361VENTO Fixation Screw1-01-12-91502017-12-18
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

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Primary DI, Brand, Company table
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