Conformis, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts, Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System, iTotal Identity Knee Replacement System
60
Total
60
Cleared
0
Denied
FDA 510(k) Regulatory Record - Conformis, Inc. Orthopedic ✕
59 devices
Cleared
Sep 08, 2023
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)...
Orthopedic
28d
Cleared
Jul 21, 2023
Identity Imprint Porous Total Knee Replacement System, Identity Imprint...
Orthopedic
266d
Cleared
Jul 17, 2023
iTotal Identity Knee Replacement System
Orthopedic
111d
Cleared
May 26, 2023
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
Orthopedic
28d
Cleared
May 23, 2023
ACTERA™ hip system
Orthopedic
27d
Cleared
Apr 27, 2023
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with...
Orthopedic
30d
Cleared
Aug 04, 2022
Actera™ hip system
Orthopedic
112d
Cleared
Jul 26, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
Orthopedic
71d
Cleared
May 10, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
Orthopedic
29d
Cleared
Nov 10, 2021
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity...
Orthopedic
26d
Cleared
Sep 23, 2021
Identity Imprint Knee Replacement System (including Identity Imprint...
Orthopedic
51d
Cleared
May 12, 2021
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
Orthopedic
56d
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