FDA.reportPublic FDA data

STRYKER PUERTO RICO, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26486662648666STRYKER PUERTO RICO, LLC.1Y2026-01-01HWY. 3, KM. 131.2 LAS GUASIMAS IND. PARK ARROYO PR US 00714

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37881606134061K981717STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORFTD1998-06-30
37881638151489K972233STRYKER WEDGE INTERFERENCE SCREW SYSTEMHWC1997-08-05
37881187390258K952460STRYKER ACL INTERFERENCE SCREW SYSTEMHWC1995-09-28
37881172904799K944210ARTHROSCOPE ACCESSORIESHRX1995-02-14
37881947854556K943540SURGICAL CUTTING BURSDZJ1994-11-30
37881720862681K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
37881747540583K912190STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYSTJDZ1991-08-29
37881093391162K910512ACCUFLATEKCY1991-02-19
37881900637096K251643Synchfix EVTHTN2025-10-29
37881701289079K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPML2020-03-31
37881394685657K190070Sonopet iQ Ultrasonic Aspirator SystemLFL2019-04-11
37881075490130K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-12-21
37881252313397K180327Stryker iVAS 13g Bone Biopsy KitKNW2018-02-26
37881266127801K172921Stryker Self-Punching ICONIXMBI2017-11-20
37882022530595K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNW2017-10-05
37881047482480K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-01-25
37881380719768K171465Stryker Self-Punching ICONIXMBI2017-08-24
37881533940802K170098ICONIX TT All Suture AnchorMBI2017-03-31
37881365259774K151314CinchLock Flex Knotless Suture AnchorMBI2015-07-23
37881011436306K151201Stryker ICONIX with NeedlesMBI2015-06-29
37881588061265K150584Stryker Suture TapeGAT2015-08-13
37882054224972K150416ProCinch Adjustable Loop DeviceHTY2015-04-17
37881297437362K141673IVAS 8 GAUGE BONE BIOPSY KITKNW2014-09-04
37881211388443K133671ICONIX ALL SUTURE ANCHORSMBI2014-02-28
37881757566449K131769CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MMMBI2013-10-07
37881368432924K130430IVAS 10MM AND 15MM BALLOON CATHETERHRX2013-05-23
37881989811180K123942STRYKER IVAS BALLOON CATHETERNDN2013-04-03
37881094037280K1208243.9MM REELX STT SUTURE ANCHOR SYSTEMMBI2012-07-18
37881566484531K120509STRYKER ALL SUTURE ANCHORSMBI2012-07-26
37881787772737K113477IVAS 20MM (10 GAUGE) BALLOON CATHETERNDN2012-01-06
37881995857065K113154IVAS BALLOON CATHETERNDN2012-01-24
37881486084126K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMERL2012-05-01
37881562271095K103807IVAS 2-10MM (10 GUAGE) BALLON CATHETERNDN2011-06-28
37881157907198K093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASNDN2010-03-18
37881789058091K073633STRYKER ESSX MICRODEBRIDER SYSTEMERL2008-08-26
37881073429262K072118STRYKER VERTAPLEX RADIOPAQUE BONE CEMENTNDN2007-12-07
37881619804757K071157STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORSHWC2007-09-17
37881286111643K070882STRYKER PEEK TWINLOOP TACMBI2007-07-20
37881127393703K070758STRYKER PEEK ZIP SUTURE ANCHORMBI2007-05-16
37881705053235K050753STRYKER DISCMONITORFMF2005-05-18
37881429361343K042457URO PROLJH2004-10-25
37881341382032K041310STRYKER WEDGE SUTURE ANCHOR SYSTEMMBI2004-06-14
37881752329962K032945SIMPLEX XLOD2004-05-25
37881855628271K032943STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITSKNW2003-12-17
37881495763128K032473DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBEHRX2003-11-07
37881435348303K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMHBE2004-01-16
37881267565096K032117STRYKER TOTAL PERFORMANCE (TPS) SYSTEMDZI2003-08-08
37881617345823K03083740 L HIGH FLOW INSUFFLATOR F108HIF2004-02-05
37882047618934K013513DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBEHRX2002-01-17
37881485025849K011381HUMMER IV MICRODEBRIDER SYSTEMERL2001-05-25
37881949611911K003792STRYKER HEATED INSUFFLATOR TUBE SETHIF2001-02-21
37881035153527
37881073429262
37881083817505
37881277198517
37881317411604
37881362682015
37881397622904
37881406486892
37881423491360
37881471920666
37881613540198
37881666627642
37881715998030
37881720862681
37881767587322
37881830376603
37881837222018
37881843207479
37881900637096
37881905305435
37881932490381
37881967041478
37881980643301
37881985136845
37882013258972
37882046517753

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI122017-11-20
HRX62018-12-21
NDN62013-04-03
KNW42018-02-26
ERL32012-05-01
HWC32007-09-17
HIF22004-02-05
HTN12025-10-29
PML12020-03-31
LFL12019-04-11
GAT12015-08-13
HTY12015-04-17
FMF12005-05-18
LJH12004-10-25
LOD12004-05-25
HBE12004-01-16
DZI12003-08-08
FTD11998-06-30
DZJ11994-11-30
LXH11994-08-05
JDZ11991-08-29
KCY11991-02-19