GMK Primary Total Knee System

GUDID 07630030816055

Full-PE PS Tibial Component #1/14

Medacta International SA

Uncoated knee tibia prosthesis, polyethylene

Primary Device ID	07630030816055
NIH Device Record Key	d20d361d-ea5f-45ce-a0c6-da67b337027a
Commercial Distribution Status	In Commercial Distribution
Brand Name	GMK Primary Total Knee System
Version Model Number	02.07.0114APPS
Company DUNS	488227125
Company Name	Medacta International SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030816055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131310

FDA Product Code

JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-11
Device Publish Date	2014-11-18

On-Brand Devices [GMK Primary Total Knee System]

07630030822667	Primary extension stem Ø11mm, 65mm
07630030822643	Primary Extension Stem Ø 11, 30 mm
07630030821059	Femur Narrow cemented PS Right, size 7
07630030821042	Femur Narrow cemented PS Left, size 7
07630030821035	Femur Narrow cemented PS Right, size 6
07630030821028	Femur Narrow cemented PS Left, size 6
07630030821011	Femur Narrow cemented PS Right, size 5
07630030821004	Femur Narrow cemented PS Left, size 5
07630030820991	Femur Narrow cemented PS Right, size 4
07630030820984	Femur Narrow cemented PS Left, size 4
07630030820977	Femur Narrow cemented PS Right, size 3
07630030820960	Femur Narrow cemented PS Left, size 3
07630030820953	Femur Narrow cemented PS Right, size 2
07630030820946	Femur Narrow cemented PS Left, size 2
07630030820939	Femur Narrow cemented PS Right, size 1
07630030820922	Femur Narrow cemented PS Left, size 1
07630030820915	Femur PS cemented Right, size 7
07630030820908	Femur PS cemented Left, size 7
07630030820892	Femur PS cemented right, size 6
07630030820885	Femur PS cemented left, size 6
07630030820878	Femur PS cemented right, size 5
07630030820861	Femur PS cemented left, size 5
07630030820854	Femur PS cemented right, size 4
07630030820847	Femur PS cemented left, size 4
07630030820830	Femur PS cemented right, size 3
07630030820823	Femur PS cemented left, size 3
07630030820816	Femur PS cemented right, size 2
07630030820809	Femur PS cemented left, size 2
07630030820793	Femur PS cemented right, size 1
07630030820786	Femur PS cemented left, size 1
07630030820779	Femur PS cemented Right, size 0
07630030820762	Femur PS cemented Left, size 0
07630030820427	Femur Narrow cemented STD Right, size 7
07630030820410	Femur Narrow cemented STD Left, size 7
07630030820403	Femur Narrow cemented STD Right, size 6
07630030820397	Femur Narrow cemented STD Left, size 6
07630030820380	Femur Narrow cemented STD Right, size 5
07630030820373	Femur Narrow cemented STD Left, size 5
07630030820366	Femur Narrow cemented STD Right, size 4
07630030820359	Femur Narrow cemented STD Left, size 4
07630030820342	Femur Narrow cemented STD Right, size 3
07630030820335	Femur Narrow cemented STD Left, size 3
07630030820328	Femur Narrow cemented STD Right, size 2
07630030820311	Femur Narrow cemented STD Left, size 2
07630030820304	Femur Narrow cemented STD Right, size 1
07630030820298	Femur Narrow cemented STD Left, size 1
07630030820281	Femur STD cemented Right, size 7
07630030820274	Femur STD cemented Left, size 7
07630030820267	Femur STD cemented right, size 6
07630030820250	Femur STD cemented left, size 6