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)

Premarket Exempt

No Yes

Clear

ITOTAL IDENTITY TIBIAL CUT GUIDE LARGE RIGHT - 00810933030551 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL CORING TOOL - 00810933030568 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY 15MM STEM DRILL - 00810933030575 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY IMPACTOR HANDLE - 00810933030582 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY IMPACTOR ADAPTER - 00810933030599 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY TIBIAL TRAY IMPACTOR TIP - 00810933030605 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY OVAL PATELLA HEAD SIZER 29-32-35MM - 00810933030612 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY OVAL PATELLA HEAD SIZER 38-41-44MM - 00810933030629 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY ROUND PATELLA HEAD SIZER 29-32-35MM - 00810933030636 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

ITOTAL IDENTITY ROUND PATELLA HEAD SIZER 38-41-44MM - 00810933030643 Catalog Number :

Device Class : 2

Duns Number: 808821883

Premarket Exempt : No

Product Code : OOG, OIY

Prescription Use : Yes

Device Count : 1

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