Conformis, Inc.

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

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Filters

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

No Yes

Clear

Identity Imprint Knee Replacement System - M572TPS030183S011 Catalog Number : TPS-030-183S

Device Description : PS TIBIAL INSERT TRIAL SIZE 3 18MM LEFT AND RIGHT

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 - M572TPS030184N011 Catalog Number : TPS-030-184N

Device Description : PS TIBIAL INSERT TRIAL SIZE 4 NARROW 18MM LEFT AND 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 - M572TPS030184S011 Catalog Number : TPS-030-184S

Device Description : PS TIBIAL INSERT TRIAL SIZE 4 18MM LEFT AND 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 - M572TPS030185N011 Catalog Number : TPS-030-185N

Device Description : PS TIBIAL INSERT TRIAL SIZE 5 NARROW 18MM LEFT AND 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 - M572TPS030185S011 Catalog Number : TPS-030-185S

Device Description : IDENTITY IMPRINT PS TIBIAL INSERT TRIAL SIZE 5 18MM LEFT AND 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 - M572TPS030186N011 Catalog Number : TPS-030-186N

Device Description : PS TIBIAL INSERT TRIAL SIZE 6 NARROW 18MM LEFT AND 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 - M572TPS030186S011 Catalog Number : TPS-030-186S

Device Description : PS TIBIAL INSERT TRIAL SIZE 6 18MM LEFT AND 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 - M572TPS030187S011 Catalog Number : TPS-030-187S

Device Description : PS TIBIAL INSERT TRIAL SIZE 7 18MM LEFT AND RIGHT

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

iTotal Identity Posterior Stabilized Knee Replacement System - M572TPS1011112011 Catalog Number : TPS-101-1112

Device Description : ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED)

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

iTotal Identity PS - M572TPS1011112111 Catalog Number : TPS-101-1112

Device Description : ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED), RIGHT or left

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : JWH, OIY, OOG

Prescription Use : Yes

Device Count : 1

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