Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
Conformis, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004153240 | 3004153240 | ConforMIS, Inc. | 1 | N | 2026-01-01 | 600 Research Dr Wilmington MA US 01887 |
| 3009844603 | 3009844603 | CONFORMIS, INC. | 1 | N | 2020-04-25 | 600 TECHNOLOGY PARK DR STE 3 Billerica MA US 01821 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810933031114 | Cordera Hip System Offset Cup Impactor, Enztec - Offset Cup Impactor, Enztec | 781-345-9001 | customer-service@conformis.com |
| 00810933031183 | Cordera Hip System Radel Liner Impactors 28mm - Radel Liner Impactors 28mm | 781-345-9001 | customer-service@conformis.com |
| 00810933031190 | Cordera Hip System Radel Liner Impactors 32mm - Radel Liner Impactors 32mm | 781-345-9001 | customer-service@conformis.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 183816 | 1308546279 | K252067 | Velora Acetabular System | LPH | 2025-12-05 |
| 183816 | 1817223091 | K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | MBH | 2025-03-27 |
| 183816 | 1490874842 | K231178 | ACTERA™ hip system | MEH | 2023-05-23 |
| 183816 | 1506378697 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | JWH | 2023-04-27 |
| 183816 | 1953784369 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | MBH | 2023-07-21 |
| 183816 | 2031130400 | K210809 | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) | JWH | 2021-05-12 |
| 183816 | 2012170668 | K210191 | Identity Imprint Knee Replacement System | JWH | 2021-05-06 |
| 183816 | 1224227182 | K203421 | Triathlon AS-1 | OOG | 2021-04-19 |
| 183816 | 1140041547 | K202484 | Cordera Hip System | LPH | 2020-09-24 |
| 183816 | 1551609988 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | JWH | 2020-06-16 |
| 183816 | 1773426249 | 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 |
| 183816 | 1306924550 | K192198 | Conformis Hip System | LPH | 2019-11-06 |
| 145388 | 1306924550 | K192198 | Conformis Hip System | LPH | 2019-11-06 |
| 145388 | 1787769780 | K190904 | Conformis BeneFIT Hip System | LPH | 2019-08-28 |
| 183816 | 1787769780 | K190904 | Conformis BeneFIT Hip System | LPH | 2019-08-28 |
| 183816 | 1003103126 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | JWH | 2019-08-08 |
| 145388 | 1003103126 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | JWH | 2019-08-08 |
| 183816 | 1580662984 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | 2018-05-16 |
| 145388 | 1580662984 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | 2018-05-16 |
| 183816 | 1425444142 | K170226 | iTotal Family Reusable Instrument Tray | KCT | 2017-10-25 |
| 145388 | 1425444142 | K170226 | iTotal Family Reusable Instrument Tray | KCT | 2017-10-25 |
| 145388 | 1041796036 | K162719 | iTotal® Hip Replacement System | LPH | 2017-06-14 |
| 183816 | 1041796036 | K162719 | iTotal® Hip Replacement System | LPH | 2017-06-14 |
| 183816 | 1712286675 | K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | JWH | 2016-07-15 |
| 145388 | 1712286675 | K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | JWH | 2016-07-15 |
| 183816 | 1097838680 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | JWH | 2016-06-14 |
| 145388 | 1097838680 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | JWH | 2016-06-14 |
| 183816 | 1010333536 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | 2016-03-07 |
| 145388 | 1010333536 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | 2016-03-07 |
| 183816 | 1108607246 | K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | 2016-03-25 |
| 145388 | 1108607246 | K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | 2016-03-25 |
| 145388 | 1596824933 | K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System | JWH | 2016-01-07 |
| 183816 | 1596824933 | K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System | JWH | 2016-01-07 |
| 183816 | 1671669546 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System | JWH | 2015-10-21 |
| 145388 | 1671669546 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System | JWH | 2015-10-21 |
| 145388 | 1188286333 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | JWH | 2014-12-11 |
| 183816 | 1188286333 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | JWH | 2014-12-11 |
| 145388 | 2058293356 | K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | 2014-11-14 |
| 183816 | 2058293356 | K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | 2014-11-14 |
| 145388 | 1606816880 | K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | 2014-06-30 |
| 183816 | 1606816880 | K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | 2014-06-30 |
| 145388 | 1625478767 | K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2014-05-27 |
| 183816 | 1625478767 | K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2014-05-27 |
| 183816 | 1141117571 | K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM | JWH | 2014-03-28 |
| 145388 | 1141117571 | K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM | JWH | 2014-03-28 |
| 145388 | 1924678491 | K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | JWH | 2014-01-09 |
| 183816 | 1924678491 | K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | JWH | 2014-01-09 |
| 145388 | 2006957061 | K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | 2013-12-05 |
| 183816 | 2006957061 | K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | 2013-12-05 |
| 145388 | 1444319142 | K131467 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2013-07-18 |
| 183816 | 1444319142 | K131467 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2013-07-18 |
| 145388 | 1573460624 | K131019 | ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM | JWH | 2013-05-24 |
| 183816 | 1573460624 | K131019 | ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM | JWH | 2013-05-24 |
| 145388 | 1868207899 | K122991 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-12-20 |
| 183816 | 1868207899 | K122991 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-12-20 |
| 183816 | 2002263644 | K122870 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2013-01-14 |
| 145388 | 2002263644 | K122870 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2013-01-14 |
| 145388 | 1939594604 | K122033 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-09-27 |
| 183816 | 1939594604 | K122033 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-09-27 |
| 145388 | 1179080981 | K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | 2012-09-06 |
| 183816 | 1179080981 | K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | 2012-09-06 |
| 145388 | 2044103889 | K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-04-19 |
| 183816 | 2044103889 | K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-04-19 |
| 145388 | 1379518796 | K120068 | CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) | JWH | 2012-02-03 |
| 183816 | 1379518796 | K120068 | CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) | JWH | 2012-02-03 |
| 183816 | 1552068011 | K113378 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-02-15 |
| 145388 | 1552068011 | K113378 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2012-02-15 |
| 145388 | 1591793873 | K112780 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2011-12-15 |
| 183816 | 1591793873 | K112780 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2011-12-15 |
| 145388 | 1210693781 | K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | 2011-09-29 |
| 183816 | 1210693781 | K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | 2011-09-29 |
| 145388 | 2010172325 | K103117 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2011-01-07 |
| 183816 | 2010172325 | K103117 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | 2011-01-07 |
| 145388 | 1515743520 | K094050 | ITOTAL CR KNEE REPLACEMENT SYSTEM | JWH | 2010-09-16 |
| 183816 | 1515743520 | K094050 | ITOTAL CR KNEE REPLACEMENT SYSTEM | JWH | 2010-09-16 |
| 145388 | 1006131391 | K093513 | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | NPJ | 2009-12-16 |
| 183816 | 1006131391 | K093513 | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | NPJ | 2009-12-16 |
| 145388 | 2058816573 | K092441 | MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM | HSX | 2009-09-09 |
| 183816 | 2058816573 | K092441 | MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM | HSX | 2009-09-09 |
| 145388 | 1879759340 | K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM | HSX | 2007-11-08 |
| 183816 | 1879759340 | K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM | HSX | 2007-11-08 |
| 145388 | 1151244170 | K053488 | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | NPJ | 2006-03-09 |
| 183816 | 1151244170 | K053488 | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | NPJ | 2006-03-09 |
| 145388 | 1835455141 | K043570 | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD | HSX | 2005-03-14 |
| 183816 | 1835455141 | K043570 | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD | HSX | 2005-03-14 |
| 183816 | 1766804045 | K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | 2003-10-29 |
| 145388 | 1766804045 | K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | 2003-10-29 |
| 145388 | 1630711954 | ||||
| 183816 | 1630711954 |
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
Conformis, Inc.
ConforMIS, Inc.
Conformis, Inc.
Conformis, Inc.
ConforMIS, Inc.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
ConforMIS, Inc.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
CONFORMIS, INC.
2022-03-07
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2016-10-24
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2018-08-06
2018-07-30
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