FDA.reportPublic FDA data

ARCH Medical Solutions - Elmhurst

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14244343002795782ARCH Medical Solutions - Elmhurst1N2026-01-01612 W Lamont Rd Elmhurst IL US 60126

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
565311122913737P060023BRYAN CERVICAL DISC PROSTHESISMJO2009-05-12
565311587230811K984578SYNERGY D2 SPINAL IMPLANTSMNI1999-03-23
565311337370130K974749SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMSMNH1998-03-13
565311822154991K950709SYNERGY TI ANTERIOR SPINAL SYSTEMKWQ1995-10-25
565311040700242K950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMMNH1997-01-16
565311106960261K940631CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEMMNH1995-07-13
565311744189545K181820Medline Unite Mini Plates and ScrewsHRS2018-11-01
565311440031877K162829Medline UNITE® Ankle Fracture Plating SystemHRS2016-12-09
565312033264246K151235Medline Foot Plates and ScrewsHRS2015-08-06
565312003007496K120359ORTHOLOC 3DI HALLUX SYSTEMHRS2012-05-03
565311043340286K113593NEXTGEN ALTIUS OCT SYSTEMKWP2012-04-17
565311557758508K113528CLYDESDALE(R) SPINAL SYSTEMMAX2011-12-20
565311070918318K113014CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWSHRS2012-01-31
565311987850326K111432EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWSHRS2011-08-19
565311117711012K111264CORNERSTONE (R) PSR CERVICAL FUSION SYSTEMODP2011-10-12
565311445031806K110963ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMKWP2011-05-05
565311277568904K110360PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDESHSN2011-12-16
565311428115399K103111FORZA SPACER SYSTEMMAX2011-03-23
565311583943613K102352EVOLVE EPS ORTHOLOCHRS2010-12-02
565311790763466K102195SP-FIX SPINOUS PROCESS FIXATION PLATEKWP2011-01-19
565311324355780K100886INBONE II TOTAL ANKLE REPLACEMENTHSN2010-08-26
565311566422703K100137SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGESKTT2010-06-10
565311514700697K094042PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2010-06-30
565311641622114K090857VALOR ANKLE FUSION NAIL SYSTEMHSB2009-07-14
565311651052813K090565ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEMKWP2009-06-30
565311146508206K082235BLACKSTONE PILLAR XL PEEK SPACERSMAX2008-09-04
565312004720728K081684BLACKSTONE PEDICLE SCREW SYSTEMNKB2008-09-15
565312058269694K080133MOUNTABLE ENDOSCOPIC BLADEEMF2008-03-13
565311879052525K080071SIDEKICK RAIL FIXATORKTT2008-02-07
565311669550716K073285PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2008-05-15
565311391880714K071377POLARIS BE RODSKWP2007-08-06
565311612137219K071033T2 XVBR SPINAL SYSTEMMQP2007-08-14
565311318882697K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-04-19
565312058400157K052005R&R EXTERNAL FIXATION SYSTEMKTT2005-09-06
565312070122115K051246CONSTRUX MINI PEEK VBR SYSTEMMQP2005-06-14
565311753766315K051023TOPEZ TOTAL ANKLE REPLACEMENTHSN2005-11-15
565311592728484K043338BLAKSTONE LAMINOPLASTY FIXATION SYSTEMNQW2005-02-18
565311174488700K043174STEALTH FUSION SYSTEM, MODEL RR 1000KTT2005-02-07
565311467962169K041449SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEATKWP2004-07-01
565311156308133K040938RADIAL NAIL SYSTEMHRS2004-07-01
565311243336989K030197BLACKSTONE POSTERIOR CERVICAL SYSTEMKWP2003-06-12
565311471603428K011437SYNERGY 4.0 MM, 4.5 MM VLS SCREWSMNI2001-06-06
565311003190012
565311020295078
565311100708078
565311160188343
565311251031424
565311348124469
565311477606883
565311612810903
565311694654027
565311763316354
565311763697142
565311835666690
565311849800802
565311894717843
565311040700242
565311043340286
565311070918318
565311095979566
565311106960261
565311117711012
565311122913737
565311123342280
565311146508206
565311156308133
565311174229256
565311174488700
565311243336989
565311277568904
565311318882697
565311324355780
565311337370130
565311391739326
565311391880714
565311428115399
565311440031877
565311443926619
565311445031806
565311467962169
565311471603428
565311514700697
565311557758508
565311566422703
565311583943613
565311584379237
565311587230811
565311592728484
565311612137219
565311641622114
565311651052813
565311669550716
565311744189545
565311753766315
565311790763466
565311822154991
565311879052525
565311987850326
565312003007496
565312004720728
565312033264246
565312037168233
565312058269694
565312058400157
565312070122115

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS82018-11-01
KWP72012-04-17
KTT42010-06-10
MAX32011-12-20
HSN32011-12-16
MNH31998-03-13
OVE22010-06-30
MQP22007-08-14
KWQ22007-04-19
MNI22001-06-06
ODP12011-10-12
HSB12009-07-14
MJO12009-05-12
NKB12008-09-15
EMF12008-03-13
NQW12005-02-18