FDA.reportPublic FDA data

OBERG MEDICAL PRODUCTS COMPANY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036399203003639920OBERG MEDICAL PRODUCTS COMPANY1N2026-01-01273 N Pike Rd Sarver PA US 16055

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
201591926236443K142807ANTHEM PS Total Knee SystemJWH2014-12-22
201591628579379K133947IRIX-A LUMBAR INTEGRATED FUSION SYSTEMOVD2014-07-29
201591296329154K122163CERTEX SPINAL IMPLANT SYSTEMMNI2012-10-31
201591582598860K121936NAVIOPFSOLO2012-11-30
201591282715092K121349IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHERHWC2012-07-18
201591318423697K120832FORTEX PEDICLE SCREW SYSTEMMNH2012-10-23
201591811464811K120291OP SPINE SYSTEMOSH2012-04-16
201591961590802K111086ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEMHRS2011-06-17
201591878949984K110998AFFIRM (TM) VCF SYSTEMNDN2011-10-25
201591039215949K110959ORTHOPEDIATRICS BLADE PLATE SYSTEMHRS2011-08-05
201591706146434K101700IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEMHWC2010-10-12
201591152217378K101471AXLE INTERSPINOUS FUSION SYSTEMKWP2010-11-24
201591286508701K100240ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEMHRS2010-05-17
201591055729892K092901EPICAGE INTERBODY FUSION DEVICEMAX2010-04-28
201591599090119K092561REJUVENATE MODULAR STEMMEH2009-10-20
201591244883524K092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISKYI2009-12-15
201591013255709K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEMHSB2009-03-11
201591752788924K083637CALIX SPINAL IMPLANT SYSTEMODP2009-04-20
201591066597198K083286ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEMHRS2009-01-30
201591061563435K082949ORTHOPEDIATRICS BONE SCREWSHWC2008-11-25
201591751706420K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-10-17
201591094544134K081407ORTHOPEDIATRICS PEDIPLATES SYSTEMHRS2008-07-22
201591523798812K081097ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-06-03
201591867270101K072943BUTREX BUTTRESS PLATING SYSTEMKWQ2008-01-28
201591107611974K052292SPIDER CERVICAL PLATING (SCP) SYSTEMKWQ2005-10-21
201591417560534
201591994044844
201591027459963
201591050791263
201591073994587
201591076616873
201591079670686
201591135222271
201591220883490
201591228088702
201591240913289
201591241105439
201591247231602
201591256154867
201591295584357
201591296123027
201591303317385
201591309130204
201591336689759
201591337687515
201591360012376
201591364303174
201591370523351
201591371230635
201591391859577
201591400716667
201591403329920
201591443547055
201591475995688
201591513687093
201591521777978
201591528232917
201591633439055
201591640039307
201591699870957
201591713876135
201591733913492
201591815223891
201591852347785
201591928342165
201591975525440
201591990045456
201591996388211
201592003825980
201592031775898
201592045717085
201592058808831

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS52011-08-05
HWC32012-07-18
HTY22008-10-17
KWQ22008-01-28
JWH12014-12-22
OVD12014-07-29
OLO12012-11-30
MNI12012-10-31
MNH12012-10-23
OSH12012-04-16
NDN12011-10-25
KWP12010-11-24
MAX12010-04-28
KYI12009-12-15
MEH12009-10-20
ODP12009-04-20
HSB12009-03-11