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Conformis, Inc.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30
Categories6
Latest Approval2023-09-08
TypeNumberDevice NameCodeDate
510(k) K232426 Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts MBH 2023-09-08 View
510(k) K223316 Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System MBH 2023-07-21 View
510(k) K230846 iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System JWH 2023-07-17 View
510(k) K231233 Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS JWH 2023-05-26 View
510(k) K231178 ACTERA™ hip system MEH 2023-05-23 View
510(k) K230844 Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert JWH 2023-04-27 View
510(k) K221104 Actera™ hip system MEH 2022-08-04 View
510(k) K221404 Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) JWH 2022-07-26 View
510(k) K221059 Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) JWH 2022-05-10 View
510(k) K213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System JWH 2021-11-10 View
510(k) K212411 Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) JWH 2021-09-23 View
510(k) K210809 iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) JWH 2021-05-12 View
510(k) K210191 Identity Imprint Knee Replacement System JWH 2021-05-06 View
510(k) K203421 Triathlon AS-1 OOG 2021-04-19 View
510(k) K210252 iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System JWH 2021-02-17 View
510(k) K203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement JWH 2020-12-22 View
510(k) K202484 Cordera Hip System LPH 2020-09-24 View
510(k) K201023 iTotal® Identity Posterior Stabilized Knee Replacement System JWH 2020-06-16 View
510(k) K193105 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System JWH 2020-03-13 View
510(k) K192198 Conformis Hip System LPH 2019-11-06 View
510(k) K190904 Conformis BeneFIT Hip System LPH 2019-08-28 View
510(k) K190562 iTotal Identity Cruciate Retaining Knee Replacement System JWH 2019-08-08 View
510(k) K180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System JWH 2018-05-16 View
510(k) K170226 iTotal Family Reusable Instrument Tray KCT 2017-10-25 View
510(k) K162719 iTotal® Hip Replacement System LPH 2017-06-14 View
510(k) K161668 ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) JWH 2016-07-15 View
510(k) K161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) JWH 2016-06-14 View
510(k) K153721 iTotal Cruciate Retaining (CR) Knee Replacement System JWH 2016-03-25 View
510(k) K160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System JWH 2016-03-07 View
510(k) K153217 ConforMIS iTotal Posterior Stabilized Knee Replacement System JWH 2016-01-07 View