FDA.reportPublic FDA data

Stephanie Lynch

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80310005634Stephanie Lynch1N2027-01-011800 W Center St Warsaw IN US 46580
96133503005233524Stephanie Lynch1N2027-01-011800 W Center St Warsaw IN US 46580
30028065353002806535Stephanie Lynch1N2027-01-011800 W Center St Warsaw IN US 46580
30069462793006946279Stephanie Lynch1N2027-01-011800 West Center Street Warsaw IN US 46580
30079230963007923096Stephanie Lynch1N2027-01-011800 West Center Street Warsaw IN US 46580
30079638273007963827Stephanie Lynch1N2027-01-011800 W Center St Warsaw IN US 46580
30152071553015207155Stephanie Lynch1N2027-01-011800 W Center St Warsaw IN US 46580
30091859733009185973Stephanie Lynch1N2026-01-011800 West Center Street Warsaw IN US 46580
30123923193012392319Stephanie Lynch1N2026-01-011800 W Center St Warsaw IN US 46580
30127254513012725451Stephanie Lynch1N2026-01-011800 W Center St Warsaw IN US 46580
30143027843014302784Stephanie Lynch1N2026-01-011800 West Center Street Warsaw IN US 46580
30353668903035366890Stephanie Lynch1N2026-01-011800 West Center Street Warsaw, IN US 46580 Warsaw IN US 46580
30481479613048147961STEPHANIE LYNCH1N2026-01-011800 W Center St Warsaw IN US 46580

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3349621430643488P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMNJL2007-12-10
1094092021225455P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMNJL2007-12-10
2114231233374689P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1645581366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1087751366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1220211366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
3349622036867809N17755ZIMMER(R) BONE CEMENTLOD1976-05-17
3357482036867809N17755ZIMMER(R) BONE CEMENTLOD1976-05-17
3349621546684450K994326ASCENT KNEE SYSTEMKWH2000-01-07
3357481546684450K994326ASCENT KNEE SYSTEMKWH2000-01-07
3349621609664671K994286ZMR HIP SYSTEM-POROUS REVISIONLPH2000-03-10
3349621473974384K994184PLR SPLINED REVISION STEMLZO2000-02-15
3357481473974384K994184PLR SPLINED REVISION STEMLZO2000-02-15
3349621479477712K994038MODULAR REACH HIPLPH1999-12-22
3357481479477712K994038MODULAR REACH HIPLPH1999-12-22
3349621889624329K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
3357481889624329K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
3349621344064367K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
3357481344064367K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
3349621060324026K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
3357481060324026K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
3349621820950957K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
3357481820950957K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
1087751795944773K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATEHRS2000-01-11
3349621545522133K993438METAL ON METAL ACETABULAR SYSTEMKWA2000-05-18
3357481545522133K993438METAL ON METAL ACETABULAR SYSTEMKWA2000-05-18
230951529641598K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
3349621814367727K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
3357481814367727K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
3349621269288386K993111ASCENT KNEE SYSTEMJWH1999-10-05
3357481269288386K993111ASCENT KNEE SYSTEMJWH1999-10-05
3349621149753952K992667ZMR HIP SYSTEM-REVISION TAPERLPH1999-10-27
3349621093991422K992301REUNITE SCREWSHWC1999-09-01
3357481093991422K992301REUNITE SCREWSHWC1999-09-01
3349622029295835K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
3357482029295835K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
2179511202186839K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
3349621202186839K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
3357481202186839K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
3349621318788485K991990TRI-POLAR SYSTEMKWY1999-09-10
3357481318788485K991990TRI-POLAR SYSTEMKWY1999-09-10
3349621142283966K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
3357481142283966K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
3349621406099747K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
3357481406099747K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
1087751429924188K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
2153441551899169K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
3349621816661581K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
3357481816661581K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
3349621367291059K991763LACTOSORB HAND SYSTEMHRS1999-07-30
3357481367291059K991763LACTOSORB HAND SYSTEMHRS1999-07-30
1094091321022132K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
3349621323858217K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
3357481323858217K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
2153441347248269K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
1087752030921014K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
3349621636693907K991428ASCENT KNEE SYSTEMJWH1999-05-21
3357481636693907K991428ASCENT KNEE SYSTEMJWH1999-05-21
3349621355088889K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
3357481355088889K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
1087751425224317K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
1087751168462544K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTSLPH2000-04-11
3349621474020183K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTSLPH2000-04-11
3349621633976488K990291LACTOSORB BONE PINHTY1999-03-23
3357481633976488K990291LACTOSORB BONE PINHTY1999-03-23
2153442012375802K990291LACTOSORB BONE PINHTY1999-03-23
230951754236275K990137ANATOMICA HUMERAL STEM/HEAD COMPONENTSKWS1999-02-18
230951295201996K990136ANATOMICA GLENOID COMPONENTKWS1999-03-01
2153441436009616K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
3349622032594018K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
3357482032594018K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
1220211756435945K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEHSB1999-02-01
1087751838176444K990032MODULAR PROTUSIO CUPJDI1999-02-18
1087751800594641K984408130 MODIFIED INTEGRAL FEMORAL COMPONENTLPH1999-02-12
3349621396097916K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
3357481396097916K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
2114231215544427K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
3349621935627807K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
3357481935627807K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
3349621364715020K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDHWC1999-02-03
3357481364715020K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDHWC1999-02-03
1087751740273925K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
3349621863557780K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
3357481863557780K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
3349621434771267K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
3357481434771267K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
1220211399677586K983853DEPUY ACE TIMAX META PLATEHRS1998-12-22
1087751596900666K983710150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISHJDI1998-12-02
230951260061966K983592SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWSHWC1999-01-28
3349621048171554K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
3357481048171554K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
2114231297342281K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
3349621809786446K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
3357481809786446K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
3349621637879007K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
3357481637879007K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
3349621875892932K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
3357481875892932K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
3349621422002397K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
3357481422002397K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
3349622010297042K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
3357482010297042K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
3349621855523636K982869ASCENT SYSTEMJWH1998-09-22
3357481855523636K982869ASCENT SYSTEMJWH1998-09-22
3349621899195295K982545BMP CABLE SYSTEMJDQ1998-10-19
3357481899195295K982545BMP CABLE SYSTEMJDQ1998-10-19
2153441328288070K982367REACH HIP COMPONENTLPH1998-08-24
3349621532182618K982367REACH HIP COMPONENTLPH1998-08-24
3357481532182618K982367REACH HIP COMPONENTLPH1998-08-24
2114231554240611K982367REACH HIP COMPONENTLPH1998-08-24
3349621444883188K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
3357481444883188K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
2153441324334729K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
3349621364105417K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
3357481364105417K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
1087751760728559K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
3349621707994573K981789LORENZ PECTUS SUPPORT BAR STABILIZERHRS1998-07-13
1087751726188136K981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATEHRS1998-07-29
3349621751632964K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
3357481751632964K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPH1842026-05-19
JWH1702021-09-28
HRS1662024-08-15
JDI1412020-07-16
HWC1102020-02-24
HSB932025-12-12
KTT862015-12-30
KWA672011-10-07
LZO642026-04-27
MBH422018-05-17
KRO402013-10-24
PHX322021-02-19
KWT292011-12-15
KWS282021-12-10
MBI282020-01-16
HRY232014-03-28
LXT222013-10-09
JDC192019-01-28
HTY192004-07-30
KWY182019-11-05
HAW152023-07-20
MBF142020-10-28
HSX132016-11-03
HSD132016-11-01
KWZ122008-01-07
MEH122002-05-31
LOD102026-04-15
HRX102008-09-09
JDR102006-07-25
JDG91994-09-20
JDW82011-02-17
KXA82007-06-29
KRR82007-06-07
LWJ82000-11-15
KWL81999-01-19
JEC71994-02-22
OLO62022-10-04
PBI62012-11-23
KWQ62011-02-02
HTN62009-09-11