FDA.reportPublic FDA data

PRECISION MEDICAL TECHNOLOGIES

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18352963000210784PRECISION MEDICAL TECHNOLOGIES1N2026-01-012059 N. POUND DR. WARSAW IN US 46582
30142734243014273424PRECISION MEDICAL TECHNOLOGIES1N2026-01-01103 Warrener Drive -- Rome City IN US 46784
30151795883015179588Precision Medical Technologies- North Manchester Manufacturing Facility1N2026-01-01400 Beckley Street N Manchester IN US 46962

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2162711626721416K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEMMBI2013-06-20
163961626721416K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEMMBI2013-06-20
2243771966286589K120998SOLSTICE CROSS CONNECTORKWP2012-10-01
2243771096492338K093200LIFE SPINE LUMBAR PLATE SYSTEMKWQ2010-01-19
2243771179951268K093093SMALL PLATEAU SPACER SYSTEMODP2010-10-13
2243771858680864K070285LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-03-13
163961016637141
163961018983785
163961063812159
163961096492338
163961113379763
163961121006813
163961179951268
163961183051475
2162711183051475
163961212872345
163961257934919
163961278630481
2162711278630481
2162711299144808
163961302288032
163961313631755
2162711313631755
163961315279324
163961319906616
163961348511263
2162711348511263
163961356400752
163961358289280
163961371740209
2162711372211270
163961372211270
2243771372211270
163961376091289
163961383910953
2162711386423443
163961386423443
2162711389113935
163961389113935
163961411039776
163961445937057
163961484813383
163961489797478
2243771498073948
163961509182373
163961543604907
163961637413463
2162711680846414
2162711686336335
2243771694629340
163961694629340
2162711694629340
163961715363683
2162711715363683
163961723272550
163961779819034
163961792227195
2162711804915142
163961804915142
163961822108093
163961841573024
2243771842850113
163961842850113
163961858680864
163961883209255
163961886713560
2243771927479833
163961927479833
163961928226596
163961966286589
2162712009088854
163962009088854
2243772030511393
2162712041095589
163962049550138
2162712060387474
163962060387474
2243772061233401

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI22013-06-20
KWQ22010-01-19
KWP12012-10-01
ODP12010-10-13