FDA.reportPublic FDA data

AGC REVISION KNEE

Primary DI
05019279387793
Brand
AGC REVISION KNEE
Company
Biomet Uk Ltd
Model
154545
Catalog number
154545
Published
2015-10-24
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
K984054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984054000AGC V2 REVISION KNEE SYSTEMBiomet, Inc.1999-07-30JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019279387793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019279387793050192793877935019279387793

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeA sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.c
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
219322575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024682481Oxford® Partial Knee System1101101031101101032026-09-04
00889024682498Oxford® Partial Knee System1101101041101101042026-09-04
00889024682504Oxford® Partial Knee System1101101051101101052026-09-04
00889024682528Oxford® Partial Knee System1101101071101101072026-09-04
00889024682535Oxford® Partial Knee System1101101081101101082026-09-04
00889024682542Oxford® Partial Knee System1101101091101101092026-09-04
00889024682559Oxford® Partial Knee System1101102031101102032026-09-04
00889024682566Oxford® Partial Knee System1101102041101102042026-09-04
00889024682573Oxford® Partial Knee System1101102051101102052026-09-04
00889024682580Oxford® Partial Knee System1101102061101102062026-09-04
00889024682603Oxford® Partial Knee System1101102081101102082026-09-04
00889024682610Oxford® Partial Knee System1101102091101102092026-09-04
00889024682634Oxford® Partial Knee System1101103041101103042026-09-04
00889024682641Oxford® Partial Knee System1101103051101103052026-09-04
00889024682665Oxford® Partial Knee System1101103071101103072026-09-04
00889024682672Oxford® Partial Knee System1101103081101103082026-09-04
00889024682696Oxford® Partial Knee System1101104031101104032026-09-04
00889024682719Oxford® Partial Knee System1101104051101104052026-09-04
00889024682733Oxford® Partial Knee System1101104071101104072026-09-04
00889024682757Oxford® Partial Knee System1101104091101104092026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.JWH2020-09-25
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