FDA.report

Sherri Mellingen

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30080211103008021110Sherri Mellingen1N2026-01-019801 Metric Blvd Ste 200 Austin TX US 78758
30124394583012439458Sherri Mellingen1N2026-01-019800 Metric Blvd Austin TX US 78758
30274846133027484613Sherri Mellingen1N2026-01-017205 Dahlgren Rd Chaska MN US 55318

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1172081009659844K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemPHX2026-01-22
1172081580821238K251718ArTT Augments and Buttresses and Bone ScrewsLPH2025-08-29
1172081290270637K250980Physica System (Physica CR Porous Femoral components)MBH2025-05-22
1172081521296147K243826SMR Reverse HP Shoulder SystemPHX2025-07-03
1172081692446871K243809Biolox® Delta Revision headsLZO2025-03-04
1172081654541440K243615Physica Porous Femoral ComponentsMBH2024-12-18
1172081234819215K234011AMF TT ConesJWH2024-01-18
1172081529672063K233712PRIMA Humeral System; PRIMA TT GlenoidMBF2024-01-11
1172082047439148K231925MINIMA S SystemLZO2023-07-11
1172081345025830K222807TEMA Elbow system - Line extensionJDB2022-10-26
1172081629891466K222427PRIMA TT GlenoidMBF2022-10-06
1172081459373186K221758SMR Stemless AnatomicPKC2023-03-17
1172081649090544K220792SMR Reverse LinerMBF2022-05-19
1172081957219069K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidKWS2022-05-13
1172082013445419K213381Physica systemJWH2021-12-17
1172081385725879K212800PRIMA Humeral System and SMR Glenosphere Ø42PHX2022-02-25
1172081200857036K210717Bone Screws dia. 5,0 mmPHX2021-07-12
1172081538826308K210554Physica systemMBH2021-04-06
1172081243120495K203475LimaCorporate Kirschner WireHTY2021-02-05
1172081636587922K201905SMR 140° Reverse Humeral BodyMBF2020-12-17
1172081918123291K201084Physica systemMBH2020-12-14
1172081780822139K200656Delta Multihole TT Pro Acetabular SystemLPH2020-07-08
1172081049007633K200653AMF Revision TT ConesJWH2020-05-07
1172081193943685K200171SMR TT Augmented Glenoid SystemPHX2020-11-19
1172081223581769K193284Physica LMC Knee SystemJWH2020-01-31
1172081151394812K191963SMR Finned Short StemsMBF2019-10-10
1172081206623793K191746SMR TT Augmented Glenoid SystemPHX2019-11-22
1172081609091621K191622Delta Multihole TT Pro Acetabular SystemLPH2019-11-01
1172081607713992K190911Physica KR Liner and SMR Reverse Humeral LinerJWH2019-11-26
1172081698421225K183042SMR Lateralized Connectors with screwsKWS2019-01-25
1172081258425805K182099Delta TT ProLPH2018-12-26
1172081178801655K181491Delta Dual Mobility SystemLZO2019-05-09
1172081372695586K181362TEMA Elbow SystemJDC2019-02-16
1172081220260834K172456Bone Screws 6.5mmLPH2018-01-04
1172081676293363K170473C2 femoral stemLZO2017-11-08
1172081441183080K163397SMR Hybrid Glenoid SystemMBF2017-06-29
1172081921273176K161476SMR Shoulder SystemKWT2016-06-24
1172081238957199K161226Revision Femoral StemLZO2017-02-10
1172081683474671K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsPHX2017-02-21
1172081381641356K160011H-Max S stemMEH2016-08-22
1172081705579640K153722SMR 3-Pegs GlenoidsKWS2016-04-06
1172081755905887K152008Physica PS Knee SystemJWH2015-10-29
1172081575231538K151739Revision Femoral StemLZO2015-11-23
1172081102656688K151266Physica CR Knee SystemJWH2015-10-06
1172081568035836K150855H-MAX S Femoral Hip SystemMEH2015-10-21
1172082002735589K143256SMR Modular GlenoidKWS2015-05-28
1172081264199824K142139SMR 40MM GLENOSPHEREPHX2014-11-07
1172081604009311K141934PHYSICA KR KNEE SYSTEMJWH2015-04-02
1172081234069987K141395DELTA TT ACETABULAR SYSTEMLPH2014-06-30
1172082022130614K141327MINIMA S SYSTEMLZO2014-08-06
1172081988339877K140975MASTERSL FEMORAL STEMLZO2014-06-10
1172081199970544K133349SMR TT METAL BACK GLENOIDKWS2014-06-03
1172081111847715K131112LIMACORPORATE SMR CTA HUMERAL HEADSKWS2013-06-07
1172081105678063K130642SMR 3-PEGS GLENOIDSKWS2013-06-12
1172081315911441K113523LIMACORPORATE SMR REVERSE SHOULDER SYSTEMPHX2011-12-20
1172081141735362K113254SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWSPHX2012-02-24
1172081654714515K112900SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSHSD2012-06-01
1172081533072516K112898DELTA TT CUPS, DELTA TT LINERS, BONE SCREWSLPH2012-12-21
1172081454951324K112158MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADSLPH2012-05-10
1172081847182647K112091H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADSMEH2012-11-09
1172081556711466K111212SMR SHOULDER SYSTEM- REVISION STEMSKWS2011-07-28
1172081598325608K110847SMR SHOULDER SYSTEM - CTA HUMERAL HEADSKWS2011-07-15
1172081015429806K110598SMR REVERSE SHOULDER SYSTEMPHX2011-08-18
1172081088038095K101263LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,KWT2011-01-28
1172081766306369K100858LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,KWT2010-12-10
1172081011939363
1172081036363433
3265971069060709
3265971116131320
3265971160714251
3265971255033112
1172081349136486
1172081363724495
1172081370003588
3265971372189253
3376111415008429
1172081457800762
1172081463254970
1172081465514778
3265971480491860
1172081490303546
1172081506593738
1172081509183737
3265971658733665
1172081679562045
1172081714806538
1172081818781450
1172081820678589
1172081821483589
3265971835780979
1172081870680270
3265971875083926
1172081961116307
1172081962583581
1172081980973266
1172081987979859
3265972012499937
1172082025148634
1172082073013346

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
PHX112026-01-22
KWS92022-05-13
LPH82025-08-29
LZO82025-03-04
JWH82024-01-18
MBF62024-01-11
MBH42025-05-22
MEH32016-08-22
KWT32016-06-24
PKC12023-03-17
JDB12022-10-26
HTY12021-02-05
JDC12019-02-16
HSD12012-06-01