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 - M572TPS101F01S011 Catalog Number : TPS-101-F01S

Device Description : PS FEMORAL IMPLANT SIZE 1 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 - M572TPS101F02N011 Catalog Number : TPS-101-F02N

Device Description : PS FEMORAL IMPLANT SIZE 2 Narrow LEFT or Right

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OIY, OOG, JWH

Prescription Use : Yes

Device Count : 1

Identity Imprint Knee Replacement System - M572TPS101F02S011 Catalog Number : TPS-101-F02S

Device Description : PS FEMORAL IMPLANT SIZE 2 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 - M572TPS101F03N011 Catalog Number : TPS-101-F03N

Device Description : PS FEMORAL IMPLANT SIZE 3 Narrow 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 - M572TPS101F03S011 Catalog Number : TPS-101-F03S

Device Description : PS FEMORAL IMPLANT SIZE 3 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 - M572TPS101F04N011 Catalog Number : TPS-101-F04N

Device Description : PS FEMORAL IMPLANT SIZE 4 Narrow 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 - M572TPS101F04S011 Catalog Number : TPS-101-F04S

Device Description : PS FEMORAL IMPLANT SIZE 4 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 - M572TPS101F05N011 Catalog Number : TPS-101-F05N

Device Description : PS FEMORAL IMPLANT SIZE 5 NARROW 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 - M572TPS101F05S011 Catalog Number : TPS-101-F05S

Device Description : PS FEMORAL IMPLANT SIZE 5 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 - M572TPS101F06N011 Catalog Number : TPS-101-F06N

Device Description : PS FEMORAL IMPLANT SIZE 6 NARROW LEFT or RIGHT

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

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