FDA.reportPublic FDA data

AMPLITUDE

Primary DI
03701089500845
Brand
AMPLITUDE
Company
AMPLITUDE SAS
Model
1-0210039
Catalog number
1-0210039
Device description
Resurfacing Patellar Implant NM Cemented Ø 39 mm
Published
2017-08-08
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161414000Anatomic Total Knee SystemAmplitude2017-01-19JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701089500845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701089500845037010895008453701089500845

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene patella prosthesisAn implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.

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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701089509695AMPLITUDE1-02007101-02007102026-07-31
03701089515153AMPLITUDE2-01024002-01024002026-07-29
03701089517492TRAX1-02084001-02084002026-07-29
03701089517508TRAX1-02084011-02084012026-07-29
03701089517515TRAX1-02084021-02084022026-07-29
03701089517522TRAX1-02084031-02084032026-07-29
03701089517539TRAX1-02084041-02084042026-07-29
03701089517546TRAX1-02084051-02084052026-07-29
03701089517553TRAX1-02084061-02084062026-07-29
03701089517560TRAX1-02084071-02084072026-07-29
03701089517577TRAX1-02084081-02084082026-07-29
03701089517584TRAX1-02085001-02085002026-07-29
03701089517591TRAX1-02085011-02085012026-07-29
03701089517607TRAX1-02085021-02085022026-07-29
03701089517614TRAX1-02085031-02085032026-07-29
03701089517621TRAX1-02085041-02085042026-07-29
03701089517638TRAX1-02085051-02085052026-07-29
03701089517645TRAX1-02085061-02085062026-07-29
03701089517652TRAX1-02085071-02085072026-07-29
03701089517669TRAX1-02085081-02085082026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00192629298682ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298828ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298835ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298842ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298859ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298866ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298873ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298880ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298897ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298903ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298910ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298927ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298934ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298941ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298958ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298965ProphecyMicroport Orthopedics Inc.JWH2020-09-25