Conformis, Inc.

Address:600 TECHNOLOGY PARK DR STE 3,Billerica,MA,01821,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Knee Arthroplasty Implantation System (OOG) (10) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) (10) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (10)

Premarket Exempt

Yes No

Clear

Identity Imprint Knee Replacement System - M572TPS101F06S011 Catalog Number : TPS-101-F06S

Device Description : PS FEMORAL IMPLANT SIZE 6 LEFT or RIGHT

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Identity Imprint Knee Replacement System - M572TPS101F07S011 Catalog Number : TPS-101-F07S

Device Description : PS FEMORAL IMPLANT SIZE 7 LEFT or RIGHT

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

iTotal PS - M572TPS1111111011 Catalog Number : TPS-111-1111

Device Description : ITOTAL PS IPOLY IMPLANT KIT LEFT or right

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

iTotal® PS - M572TPS1111111021 Catalog Number : TPS1111111

Device Description : iTotal® Posterior Stabilized (PS) Knee Replacement System

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OIY, OOG, JWH

Prescription Use : Yes

Device Count : 1

iTotal® Posterior Stabilized (PS) Knee Replacement System - M572TPS1211111021 Catalog Number : TPS1211111

Device Description : ITOTAL PS–IPOLY XE–IMPLANT KIT–LEFT or right

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OIY, OOG, JWH

Prescription Use : Yes

Device Count : 1

iTotal Identity Posterior Stabilized Knee Replacement System - M572TPS3011113011 Catalog Number : TPS-301-1113

Device Description : ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEMENTED)

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Identity Imprint Knee Replacement System - M572TPS301T01S011 Catalog Number : TPS-301-T01S

Device Description : PS TIBIAL TRAY SIZE 1

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Identity Imprint Knee Replacement System - M572TPS301T02N011 Catalog Number : TPS-301-T02N

Device Description : PS TIBIAL TRAY SIZE 2 NARROW

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, JWH, OIY

Prescription Use : Yes

Device Count : 1

Identity Imprint Knee Replacement System - M572TPS301T02S011 Catalog Number : TPS-301-T02S

Device Description : PS TIBIAL TRAY SIZE 2

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

Identity Imprint Knee Replacement System - M572TPS301T03N011 Catalog Number : TPS-301-T03N

Device Description : PS TIBIAL TRAY SIZE 3 NARROW

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

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