FDA.reportPublic FDA data

ConforMIS, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041532403004153240ConforMIS, Inc.1N2026-01-01600 Research Dr Wilmington MA US 01887
30098446033009844603CONFORMIS, INC.1N2020-04-25600 TECHNOLOGY PARK DR STE 3 Billerica MA US 01821

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810933031114Cordera Hip System Offset Cup Impactor, Enztec - Offset Cup Impactor, Enztec781-345-9001customer-service@conformis.com
00810933031183Cordera Hip System Radel Liner Impactors 28mm - Radel Liner Impactors 28mm781-345-9001customer-service@conformis.com
00810933031190Cordera Hip System Radel Liner Impactors 32mm - Radel Liner Impactors 32mm781-345-9001customer-service@conformis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1838161308546279K252067Velora Acetabular SystemLPH2025-12-05
1838161817223091K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemMBH2025-03-27
1838161490874842K231178ACTERA™ hip systemMEH2023-05-23
1838161506378697K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertJWH2023-04-27
1838161953784369K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemMBH2023-07-21
1838162031130400K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)JWH2021-05-12
1838162012170668K210191Identity Imprint Knee Replacement SystemJWH2021-05-06
1838161224227182K203421Triathlon AS-1OOG2021-04-19
1838161140041547K202484Cordera Hip SystemLPH2020-09-24
1838161551609988K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemJWH2020-06-16
1838161773426249K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement SystemJWH2020-03-13
1453881306924550K192198Conformis Hip SystemLPH2019-11-06
1838161306924550K192198Conformis Hip SystemLPH2019-11-06
1838161787769780K190904Conformis BeneFIT Hip SystemLPH2019-08-28
1453881787769780K190904Conformis BeneFIT Hip SystemLPH2019-08-28
1838161003103126K190562iTotal Identity Cruciate Retaining Knee Replacement SystemJWH2019-08-08
1453881003103126K190562iTotal Identity Cruciate Retaining Knee Replacement SystemJWH2019-08-08
1838161580662984K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemJWH2018-05-16
1453881580662984K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemJWH2018-05-16
1838161425444142K170226iTotal Family Reusable Instrument TrayKCT2017-10-25
1453881425444142K170226iTotal Family Reusable Instrument TrayKCT2017-10-25
1838161041796036K162719iTotal® Hip Replacement SystemLPH2017-06-14
1453881041796036K162719iTotal® Hip Replacement SystemLPH2017-06-14
1838161712286675K161668ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)JWH2016-07-15
1453881712286675K161668ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)JWH2016-07-15
1838161097838680K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)JWH2016-06-14
1453881097838680K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)JWH2016-06-14
1838161010333536K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement SystemJWH2016-03-07
1453881010333536K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement SystemJWH2016-03-07
1838161108607246K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemJWH2016-03-25
1453881108607246K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemJWH2016-03-25
1453881596824933K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemJWH2016-01-07
1838161596824933K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemJWH2016-01-07
1453881671669546K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement SystemJWH2015-10-21
1838161671669546K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement SystemJWH2015-10-21
1453881188286333K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemJWH2014-12-11
1838161188286333K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemJWH2014-12-11
1838162058293356K142161ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMJWH2014-11-14
1453882058293356K142161ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMJWH2014-11-14
1838161606816880K140833ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMJWH2014-06-30
1453881606816880K140833ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMJWH2014-06-30
1838161625478767K140423ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2014-05-27
1453881625478767K140423ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2014-05-27
1453881141117571K133560ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEMJWH2014-03-28
1838161141117571K133560ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEMJWH2014-03-28
1453881924678491K133256ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMJWH2014-01-09
1838161924678491K133256ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMJWH2014-01-09
1453882006957061K132640IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMHSX2013-12-05
1838162006957061K132640IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMHSX2013-12-05
1838161444319142K131467ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2013-07-18
1453881444319142K131467ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2013-07-18
1838161573460624K131019ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEMJWH2013-05-24
1453881573460624K131019ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEMJWH2013-05-24
1838161868207899K122991ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-12-20
1453881868207899K122991ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-12-20
1453882002263644K122870ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2013-01-14
1838162002263644K122870ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2013-01-14
1453881939594604K122033ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-09-27
1838161939594604K122033ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-09-27
1838161179080981K121974CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMHSX2012-09-06
1453881179080981K121974CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMHSX2012-09-06
1838162044103889K120316ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-04-19
1453882044103889K120316ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-04-19
1838161379518796K120068CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)JWH2012-02-03
1453881379518796K120068CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)JWH2012-02-03
1838161552068011K113378CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-02-15
1453881552068011K113378CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2012-02-15
1453881591793873K112780CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2011-12-15
1838161591793873K112780CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2011-12-15
1453881210693781K111916CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMHSX2011-09-29
1838161210693781K111916CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMHSX2011-09-29
1453882010172325K103117ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2011-01-07
1838162010172325K103117ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMJWH2011-01-07
1453881515743520K094050ITOTAL CR KNEE REPLACEMENT SYSTEMJWH2010-09-16
1838161515743520K094050ITOTAL CR KNEE REPLACEMENT SYSTEMJWH2010-09-16
1838161006131391K093513IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMNPJ2009-12-16
1453881006131391K093513IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMNPJ2009-12-16
1838162058816573K092441MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEMHSX2009-09-09
1453882058816573K092441MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEMHSX2009-09-09
1453881879759340K072586CONFORMIS UNI-CONDYLAR KNEE SYSTEMHSX2007-11-08
1838161879759340K072586CONFORMIS UNI-CONDYLAR KNEE SYSTEMHSX2007-11-08
1838161151244170K053488CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEMNPJ2006-03-09
1453881151244170K053488CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEMNPJ2006-03-09
1838161835455141K043570UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCDHSX2005-03-14
1453881835455141K043570UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCDHSX2005-03-14
1838161766804045K032119PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUSKCT2003-10-29
1453881766804045K032119PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUSKCT2003-10-29
1453881630711954
1838161630711954

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH552023-04-27
HSX122013-12-05
LPH82025-12-05
KCT42017-10-25
NPJ42009-12-16
MBH22025-03-27
MEH12023-05-23
OOG12021-04-19

PMN#

60 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next