FDA.reportPublic FDA data

Arch Medical Solutions - Elkhart

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099236273009923627Arch Medical Solutions - Elkhart1N2020-04-252921 Lavanture Pl Elkhart IN US 46514

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1459951710729232P100003SECURE-C ARTIFICIAL CERVICAL DISCMJO2012-09-28
1459951331618957K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemNKB2018-09-18
1459951899329392K180690Navigation InstrumentsOLO2018-06-25
1459951381220036K180210CREO® Stabilization SystemNKB2018-04-02
1459951568488324K173166ANTHEM Fracture SystemHRS2017-11-13
1459951946487860K171651EXCELSIUS GPSOLO2017-08-16
1459951619783728K153203Navigation InstrumentsOLO2016-02-03
1459951365543980K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSNKG2015-06-04
1459951320371337K132559MONUMENT SPACERSOVD2013-12-30
1459951406293031K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEMMBI2013-06-20
1459951653830415K124058CREO STABILIZATION SYSTEMOSH2013-05-13
1459951460549477K123913LATIS SPACERMAX2013-05-13
1459951047590244K122226REVERE STABILIZATION SYSTEMNKB2012-10-01
1459951225530601K121922BEACON STABILIZATION SYSTEMNKB2012-07-26
1459951661079257K121107FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)MQP2012-07-03
1459951028165002K121049UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEMKWQ2012-06-27
1459951493870551K120101INDEPENDENCE SPACEROVD2012-03-27
1459951984941594K120092PLYMOUTH THORACOLUMBAR PLATE SYSTEMKWQ2012-04-13
1459951723899779K113447RISE SPACERMAX2012-01-26
1459951592827327K113395REVERE 4.5 STABILIZATION SYSTEMNKB2012-06-14
1459952010159903K112756FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERSMQP2011-10-07
1459951111985315K112028SI-LOK SACROILIAC JOINT FIXATION SYSTEMHWC2011-12-09
1459951849399175K111479REVERE CROSSTOPNKB2011-08-17
1459951788665390K111449REVOLVE ADDITIONAL IMPLANTSNKB2011-08-17
1459951401902458K110998AFFIRM (TM) VCF SYSTEMNDN2011-10-25
1459951185831809K110963ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMKWP2011-05-05
1459951071404401K103382INTERCONTINENTAL PLATE-SPACEROVD2011-05-20
1459951119835378K103072REVERE SACRAL PLATESNKB2011-03-17
1459952001415524K102293CALIBER SPACERMAX2011-01-05
1459951511429914K093294REVERE STABILIZATION SYSTEMNKB2010-02-17
1459951073501408K093242PATRIOT TRANSCONTINENTAL LLIF SPACERMAX2009-12-23
1459951631967324K092108TRUSS THORACOLUMBAR PLATE SYSTEMKWQ2009-08-13
1459951483967496K091782REVERE 6.35 STABILIZATION SYSTEMNKB2009-08-13
1459952045613964K090952ZYFUSE FACET FIXATION SYSTEMMRW2009-07-14
1459951901159159K090565ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEMKWP2009-06-30
1459951017721055K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEMHSB2009-03-11
1459951452452510K083442CORRIDOR FIXATION SYSTEMMRW2009-02-06
1459951105744467K083389COALITION SPACEROVE2009-03-26
1459951047628453K082252INDEPENDENCE SPACEROVD2008-11-05
1459951161912160K081906PROTEX CT CERVICOTHORACIC SPINAL SYSTEMKWP2008-11-14
1459951140939660K081391VIP ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-07-03
1459951417572865K081195REVERE UNIPLANAR SCREWSNKB2008-05-28
1459951232173514K080664RELIEVE LAMINOPLASTY FIXATION SYSTEMNQW2008-07-25
1459951701969279K073439TRANSITION STABILIZATION SYSTEMNQP2009-02-20
1459951717496484K073172BEACON STABILIZATION SYSTEMNKB2007-12-13
1459951947516881K072991PATRIOT SPACERS: COLONIAL ACDFODP2008-01-18
1459951774921055K072970PATRIOT SPACERSMAX2008-01-18
1459951389197286K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-04-19
1459951331370262K062836CITADEL ANTERIOR LUMBAR PLATE SYSTEMKWQ2006-12-19
1459951790009663K062407GATEWAY THORACOLUMBAR PLATE SYSTEMKWQ2006-09-06
1459951867498696K061380RETAIN RADIOLUCENT SPACERMQP2006-06-08
1459951262728542K061202REVERE STABILIZATION SYSTEMNKB2006-07-20
1459951946825490K052069PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTESKWP2005-08-17
1459951968885467K050391PROTEX CT CERVICOTHORACIC SPINAL SYSTEMKWP2005-07-21
1459951585133718K042953MODIFICATION TO PROTEX STABILIZATION SYSTEMNKB2004-11-22
1459951739534472K040721ASSURE ANTERIOR CERVICAL PLATE SYSTEMKWQ2004-06-17
1459951269563599K040442PROTEX STABILIZATION SYSTEMMNH2004-05-20
1459951060069603K040284SUSTAIN RADIOLUCENT SPACERMQP2004-03-23
1459952071822700K031302SUSTAIN SPACERMQP2003-06-27
1459951182585465
1459951422532651
1459951781726648
1459951875783430
1459951893029050
1459952058907689

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB142018-09-18
KWQ82012-06-27
MAX52013-05-13
MQP52012-07-03
KWP52011-05-05
OVD42013-12-30
OLO32018-06-25
MRW22009-07-14
HRS12017-11-13
NKG12015-06-04
MBI12013-06-20
OSH12013-05-13
MJO 12012-09-28
HWC12011-12-09
NDN12011-10-25
OVE12009-03-26
HSB12009-03-11
NQP12009-02-20
NQW12008-07-25
ODP12008-01-18
MNH12004-05-20