FDA.reportPublic FDA data

EAGLE MEDICAL PACKAGING STERILIZATION, INC.

Matched from indexed company URL: EAGLE MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20286321000125025EAGLE MEDICAL PACKAGING STERILIZATION, INC.1N2026-01-012921 UNION RD PASO ROBLES CA US 93446

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
458352018551546K992525ACUMED MODULAR SHOULDER SYSTEMHSD2000-02-04
458351709041499K965029STABLELOC II EXTERNAL FIXATORJEC1997-02-19
458351673182096K964500ACUMED TENSION BAND PINHTY1996-12-09
458352022238056K960711ACUMED BONE GRAFT SYSTEMKIJ1996-05-07
458351491786763K953939QUINTESTSCL1995-11-13
458351504053035K952330EXTERNAL FIXATORJEC1995-10-05
458351070650494K944330ACUTRAK PLUS FIXATION SYSTEMHWC1995-05-05
458351190055700K943857EXTERNAL FIXATORJEC1995-01-27
458351914952999K942603ORTHOPAEDIC WIRESLRN1994-11-09
458351673651739K942359BONE PLATE SYSTEMHRS1995-04-13
458351042992451K942341CANNULATED CANCELLOUS BONE SCREWHWC1994-12-05
458351857777273K942340CORTICAL BONE SCREWHWC1994-12-05
458352008774087K933361ACUMED RADIUS RODHSB1994-02-22
458351445316853K931246CERCLAGE WIRE CRIMP SLEEVEJDQ1994-02-22
458351455550808K931244BONE PLATEHRS1994-02-15
458351197264077K930834ACUTRACTHWC1993-07-26
458351729622905K921480OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEMJDQ1992-06-26
458351337446105K915613BONE SCREW 3.5 MMHWC1992-02-13
458351636569884K821801NORSEN DEBRIDERGED1982-07-28
458351003314490K220892ExsoMed INnate NanoTM Lag Screw SystemHWC2022-04-27
458351604386267K213456Xenco Medical Multilevel CerviKitKWQ2021-12-21
458351290873516K190166TriMed Nitinol Staple SystemJDR2019-07-01
458351059196332K183397ChoiceSpine Stealth Cervical Spacer SystemODP2019-03-06
458351081200255K180519HARRIER-SA™ Lumbar Interbody SystemOVD2018-05-16
458351940705914K172816TiGer Shark™ SystemMAX2018-01-26
458351369877741K171489Acapella Cervical Spacer SystemOVE2017-10-23
458351745143532K161478Xenco Medical Posterior Cervical SystemNKG2016-09-06
458351791638259K160986Xenco Medical Pedicle Screw SystemNKB2016-05-04
458351404332482K160604Cure™ Anterior Cervical Plate (ACP) SystemKWQ2016-07-01
458351245887509K160313Xenco Medical Cervical Interbody SystemOVE2016-10-21
458351318693522K160198UreTron MultiProbe Lithotripter SystemFFK2016-02-23
458351669732257K152501Spinal Jaxx Interbody Fusion DeviceMAX2016-06-29
458351116786433K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedMAX2015-05-11
458351303097447K150130Ascendant TM Cervical Spacer SystemODP2015-05-28
458351107497092K143158Xenco Medical Lumbar Interbody SystemMAX2015-03-20
458351629524581K141129EXACTECH CERVICAL SPACER SYSTEMODP2014-08-15
458351104207288K130434OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTICMAX2013-05-01
458351601902508K112734APLAN A.V. FISTULA NEEDLE SETFIE2012-04-24
458351122396433K111608SLIC SCREW REPAIR SYSTEMHWC2011-08-29
458351441875381K102998CONGRUENT BONE PLATE SYSTEMHRS2011-01-04
458351678236967K101080NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXXGEI2010-06-21
458351886015254K090803HANSON MEDICAL FACIAL IMPLANTSFZE2010-06-30
458351885023778K090707TALOS INTERVERTEBRAL BODY FUSION DEVICEMAX2009-07-15
458351102267925K083167PHENIX CERVICAL INTERBODY DEVICEODP2009-01-13
458351282498288K082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEMMAX2008-09-16
458352028774596K051083ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEMHRS2005-05-12
458351842194901K041858ACUMED ANATOMIC RADIAL HEAD SYSTEMKWI2004-10-05
458351644146490K033639ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEMHWC2004-01-15
458351520619632K031438ACUMED SMALL BONE LOCKING ROD SYSTEM IIHSB2003-07-17
458351223057360K021321WRIST FUSION PLATEHRS2002-07-17
458351107370177K013616POLARUS CAP SCREWHSB2001-12-19
458351022951007K012655CONGRUENT BONE PLATE SYSTEMHRS2001-11-07
458351777951238
458351121538296
458351217379319
458351223782616
458351243644632
458351269670197
458351364049266
458351396154981
458351500839165
458351544779611
458351548670343
458351730738358
458351779985624
458351807402821
458351829949947
458351881391874
458351901897214
458352019213280

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC82022-04-27
MAX72018-01-26
HRS62011-01-04
ODP42019-03-06
HSB32003-07-17
JEC31997-02-19
KWQ22021-12-21
OVE22017-10-23
JDQ21994-02-22
JDR12019-07-01
OVD12018-05-16
NKG12016-09-06
NKB12016-05-04
FFK12016-02-23
FIE12012-04-24
FZE12010-06-30
GEI12010-06-21
KWI12004-10-05
HSD12000-02-04
HTY11996-12-09
KIJ11996-05-07
SCL11995-11-13
LRN11994-11-09
GED11982-07-28

PMN#