MOTO Partial Knee System - Medial

GUDID 07630030895906

Tibial insert fix S2 RM - 10mm

Medacta International SA

Unicondylar knee insert

Primary Device ID	07630030895906
NIH Device Record Key	bc5e7362-090a-44db-b141-eb609ae99feb
Commercial Distribution Status	In Commercial Distribution
Brand Name	MOTO Partial Knee System - Medial
Version Model Number	02.18.IF2.10.RM
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	07630030895906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162084

FDA Product Code

HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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	3
Public Version Date	2018-07-06
Device Publish Date	2017-01-05

On-Brand Devices [MOTO Partial Knee System - Medial]

07630030896842	Tibial Tray Fix Cemented S8 RM
07630030896835	Tibial Tray Fix Cemented S8 LM
07630030896828	Tibial Tray Fix Cemented S7 RM
07630030896811	Tibial Tray Fix Cemented S7 LM
07630030896804	Tibial Tray Fix Cemented S6 RM
07630030896798	Tibial Tray Fix Cemented S6 LM
07630030896781	Tibial Tray Fix Cemented S5 RM
07630030896774	Tibial Tray Fix Cemented S5 LM
07630030896767	Tibial Tray Fix Cemented S4 RM
07630030896750	Tibial Tray Fix Cemented S4 LM
07630030896743	Tibial Tray Fix Cemented S3 RM
07630030896736	Tibial Tray Fix Cemented S3 LM
07630030896729	Tibial Tray Fix Cemented S2 RM
07630030896712	Tibial Tray Fix Cemented S2 LM
07630030896705	Tibial Tray Fix Cemented S1 RM
07630030896699	Tibial Tray Fix Cemented S1 LM
07630030896682	Tibial insert fix S8 RM - 14mm
07630030896675	Tibial insert fix S8 LM - 14mm
07630030896668	Tibial insert fix S8 RM - 12mm
07630030896651	Tibial insert fix S8 LM - 12mm
07630030896644	Tibial insert fix S8 RM - 11mm
07630030896637	Tibial insert fix S8 LM - 11mm
07630030896620	Tibial insert fix S8 RM - 10mm
07630030896613	Tibial insert fix S8 LM - 10mm
07630030896606	Tibial insert fix S8 RM - 9mm
07630030896590	Tibial insert fix S8 LM - 9mm
07630030896583	Tibial insert fix S8 RM - 8mm
07630030896576	Tibial insert fix S8 LM - 8mm
07630030896569	Tibial insert fix S7 RM - 14mm
07630030896552	Tibial insert fix S7 LM - 14mm
07630030896545	Tibial insert fix S7 RM - 12mm
07630030896538	Tibial insert fix S7 LM - 12mm
07630030896521	Tibial insert fix S7 RM - 11mm
07630030896514	Tibial insert fix S7 LM - 11mm
07630030896507	Tibial insert fix S7 RM - 10mm
07630030896491	Tibial insert fix S7 LM - 10mm
07630030896484	Tibial insert fix S7 RM - 9mm
07630030896477	Tibial insert fix S7 LM - 9mm
07630030896460	Tibial insert fix S7 RM - 8mm
07630030896453	Tibial insert fix S7 LM - 8mm
07630030896446	Tibial insert fix S6 RM - 14mm
07630030896439	Tibial insert fix S6 LM - 14mm
07630030896422	Tibial insert fix S6 RM - 12mm
07630030896415	Tibial insert fix S6 LM - 12mm
07630030896408	Tibial insert fix S6 RM - 11mm
07630030896392	Tibial insert fix S6 LM - 11mm
07630030896385	Tibial insert fix S6 RM - 10mm
07630030896378	Tibial insert fix S6 LM - 10mm
07630030896361	Tibial insert fix S6 RM - 9mm
07630030896354	Tibial insert fix S6 LM - 9mm