CODA? Anterior Cervical Plate System
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1833824 | 1000115331 | Pioneer Surgical Technology, Inc. | 1 | N | 2026-01-01 | 375 RIVER PARK CIRCLE Marquette MI US 49855 |
| 1833824 | 1000115331 | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. | 1 | N | 2020-04-25 | 375 RIVER PARK CIRCLE Marquette MI US 49855 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00840298703432 | CODA™ Anterior Cervical Plate System - Primary Constrained Self Tapping Screw | +1(906)226-9909 | labelrequests@resolvesurg.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 161095 | 1569481080 | K993286 | PIONEER SILICOAT STERNAL CABLE | JDQ | 1999-11-23 |
| 161095 | 1575787234 | K992617 | HEX BUTTON | HTN | 1999-10-27 |
| 302173 | 1825745041 | K992617 | HEX BUTTON | HTN | 1999-10-27 |
| 302173 | 1563032903 | K992616 | SDB CERCLAGE SYSTEM | JDQ | 1999-10-27 |
| 161095 | 1927994535 | K992616 | SDB CERCLAGE SYSTEM | JDQ | 1999-10-27 |
| 161095 | 1384722222 | K990322 | PERRY HUMERAL NAIL | HSB | 1999-04-01 |
| 161095 | 1406582921 | K980690 | CABLE SCREW WITH INTEGRAL CRIMP | JDQ | 1998-05-22 |
| 161095 | 1505567454 | K974016 | CERCLAGE CABLE WITH HEX BUTTON | JDQ | 1997-12-19 |
| 161095 | 1455298772 | K972223 | BONE PLATE WITH CABLES | HRS | 1997-09-10 |
| 161095 | 1385210871 | K971728 | PIONEER ELEC-TROCAR DEVICE | GEI | 1997-09-19 |
| 161095 | 1402528466 | K961267 | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE | JDQ | 1996-06-27 |
| 161095 | 1976583283 | K941866 | PIONEER LABORATORIES CABLE SCREW | HWC | 1994-11-28 |
| 161095 | 1472048716 | K941213 | SONGER CABLE SYSTEM | JDQ | 1994-04-19 |
| 302173 | 1862539439 | K941213 | SONGER CABLE SYSTEM | JDQ | 1994-04-19 |
| 161095 | 1843078984 | K941174 | PIONEER LABORATORIES CABLE PIN | HWC | 1994-09-19 |
| 161095 | 1191825155 | K940729 | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES | JDQ | 1994-12-21 |
| 161095 | 1939345020 | K940690 | PIONEER LABORATORIES BONE SCREW | HWC | 1994-11-22 |
| 161095 | 1751132619 | K935481 | SPONGER CABLE SYSTEM, MODIFICATION | JDQ | 1994-01-26 |
| 161095 | 1109035726 | K922952 | SONGER CABLE SYSTEM | JDQ | 1993-02-23 |
| 302173 | 1896562569 | K230993 | CODA™ Anterior Cervical Plate System | KWQ | 2023-06-20 |
| 302173 | 1541755836 | K222493 | CODA™ Anterior Cervical Plate System | KWQ | 2022-11-18 |
| 302173 | 1112521951 | K220244 | DVR® Crosslock Wrist Spanning Plate (131849181) | HRS | 2022-04-28 |
| 302173 | 1246438378 | K201497 | EVOS Cabling System | JDQ | 2020-10-28 |
| 161095 | 1540620595 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | MAX | 2019-12-20 |
| 161095 | 1226571722 | K192396 | Streamline MIS Spinal Fixation System | NKB | 2019-11-26 |
| 161095 | 1804862962 | K183060 | CervAlign™ Anterior Cervical Plate System | KWQ | 2019-01-17 |
| 161095 | 1969832775 | K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | MAX | 2017-10-23 |
| 161095 | 1236737325 | K172139 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | 2017-08-18 |
| 161095 | 1296196001 | K170830 | Unison-C Anterior Cervical Fixation System | OVE | 2017-06-28 |
| 161095 | 1851795883 | K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | MAX | 2017-04-14 |
| 161095 | 1792158634 | K163673 | Fortilink™-C with TETRAfuse™ 3D Technology | ODP | 2017-05-23 |
| 161095 | 1028634374 | K161876 | Tritium® Sternal Cable Plate System | JDQ | 2016-09-09 |
| 161095 | 1249098226 | K161498 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | 2016-08-22 |
| 161095 | 1086165246 | K153735 | Release Laminoplasty Fixation System | NQW | 2016-01-21 |
| 302173 | 1222630150 | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables | KTT | 2015-12-30 |
| 161095 | 2047809440 | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables | KTT | 2015-12-30 |
| 302173 | 1814613748 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | JDQ | 2016-01-15 |
| 161095 | 1818509577 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | JDQ | 2016-01-15 |
| 161095 | 1927587833 | K151818 | SImmetry Sacroiliac Joint Fusion System | OUR | 2015-08-05 |
| 302173 | 1461645689 | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | HRS | 2016-01-28 |
| 161095 | 1976343822 | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | HRS | 2016-01-28 |
| 161095 | 2058261554 | K150581 | Tritium Sternal Cable Plate System | JDQ | 2015-06-04 |
| 161095 | 1113821379 | K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System | ODP | 2015-05-15 |
| 161095 | 1636996306 | K150254 | Streamline OCT Occipito-Cervico-Thoracic System | KWP | 2015-04-28 |
| 161095 | 1707453560 | K142438 | Nerve Monitoring Cable System | PDQ | 2015-03-05 |
| 161095 | 1095913056 | K141600 | NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT | MQV | 2014-10-17 |
| 161095 | 1958248147 | K141549 | SImmetry Sacroiliac Joint Fusion System | OUR | 2015-01-15 |
| 161095 | 1439127940 | K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | NKB | 2014-04-10 |
| 161095 | 1881060562 | K133623 | C-PLUS | ODP | 2014-02-10 |
| 161095 | 1525351231 | K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | MAX | 2014-03-27 |
| 161095 | 1828506380 | K132050 | NB3D BONE VOID FILLER | MQV | 2014-02-07 |
| 161095 | 1929097829 | K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | MQP | 2013-12-24 |
| 161095 | 1826232979 | K131100 | STREAMLINE TL SPINAL SYSTEM | NKB | 2013-06-27 |
| 161095 | 1984059159 | K130427 | PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2013-06-05 |
| 161095 | 1099570847 | K130286 | STREAMLINE MIS SPINAL FIXATION SYSTEM | NKB | 2013-04-01 |
| 161095 | 1352520921 | K130092 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | OUR | 2013-02-27 |
| 161095 | 1470703810 | K123478 | STINGRAY BIPOLAR FORCEPS | GEI | 2013-05-10 |
| 161095 | 1618232695 | K122293 | PIONEER STERNAL CABLE PLATE SYSTEM | HRS | 2012-10-12 |
| 161095 | 1685075237 | K121725 | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | KWP | 2012-11-07 |
| 161095 | 1234665690 | K120724 | PIONEER LATERAL PLATE SYSTEM | KWQ | 2012-05-07 |
| 161095 | 1810232081 | K120016 | PIONEER STERNAL ASSIST IMPLANT SYSTEM | HRS | 2012-07-26 |
| 161095 | 1043117096 | K112757 | PIONEER POSTERIOR CERVICO THORACIC SYSTEM | KWP | 2012-03-12 |
| 161095 | 1148602922 | K112496 | PIONEER CROSSFUSE II IBF/VBR SYSTEM | MAX | 2011-09-28 |
| 161095 | 1473939224 | K111944 | NB3D BONE VOID FILLER | MQV | 2011-11-22 |
| 161095 | 1749197316 | K111801 | SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM | OUR | 2011-07-21 |
| 161095 | 1119673680 | K111528 | PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES | KWQ | 2011-08-24 |
| 161095 | 1216404737 | K111502 | STREAMLINE TL SPINAL SYSTEM | NKB | 2011-08-23 |
| 161095 | 1028839681 | K110692 | STREAMLINE TL SPINAL SYSTEM | NKB | 2011-05-12 |
| 161095 | 1243203716 | K110561 | FORTROSS BONE VOID FILLER | MQV | 2011-04-29 |
| 161095 | 1632244095 | K110512 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | OUR | 2011-03-23 |
| 161095 | 1657829870 | K110367 | PIONEER SPINAL PROCESS FUSION PLATE | KWP | 2011-03-23 |
| 161095 | 1267422974 | K102907 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | OUR | 2010-12-14 |
| 161095 | 1733337486 | K102903 | PIONEER CANNULATED SCREW SYSTEM | HWC | 2010-10-20 |
| 161095 | 2020595821 | K101790 | QUANTUM SPINAL SYSTEM, QUANTUM MIS | NKB | 2011-03-07 |
| 161095 | 1613212940 | K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES | KWQ | 2010-06-04 |
| 161095 | 1548789602 | K100361 | NANOSS BONE VOID FILLER | MQV | 2010-04-22 |
| 161095 | 1253410449 | K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | MNH | 2010-08-10 |
| 161095 | 1190959613 | K093692 | QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES | NKB | 2010-08-11 |
| 161095 | 1534238339 | K092295 | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | KWP | 2010-02-19 |
| 161095 | 1192322695 | K091031 | PIONEER SURGICAL NANOSS BVF-E | MQV | 2009-11-17 |
| 161095 | 1024075747 | K090222 | PIONEER LUMBAR PLATE SYSTEM | KWQ | 2009-04-28 |
| 161095 | 1353882954 | K083663 | PACP | KWQ | 2009-02-25 |
| 161095 | 1517485591 | K083449 | E-MATRIX GRAFT BONE EXTENDER | MQV | 2009-06-12 |
| 161095 | 1401968248 | K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-10-31 |
| 161095 | 1849633360 | K081558 | PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC | MQV | 2008-08-25 |
| 161095 | 1779815048 | K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS | JDQ | 2008-07-01 |
| 161095 | 1585948626 | K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-07-14 |
| 161095 | 1277871074 | K080518 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | NKB | 2008-03-20 |
| 161095 | 1410170702 | K073229 | NERVE MONITORING CABLE | GXZ | 2008-06-06 |
| 161095 | 2034772588 | K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM | MAX | 2008-05-13 |
| 161095 | 1384115057 | K072703 | PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM | KWQ | 2008-01-10 |
| 161095 | 1373935312 | K070973 | QUANTUM SPINAL SYSTEM | NKB | 2007-07-03 |
| 161095 | 1643053329 | K070551 | MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | NKB | 2007-03-29 |
| 161095 | 1802473694 | K061151 | PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) | MQP | 2006-07-24 |
| 161095 | 1655883105 | K053053 | PACP SYSTEM | KWQ | 2005-11-16 |
| 161095 | 1905840757 | K043206 | PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) | MQP | 2005-01-21 |
| 161095 | 1771779413 | K043066 | PIONEER ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2005-02-03 |
| 161095 | 1486626988 | K041167 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | NKB | 2004-07-23 |
| 161095 | 1754655535 | K023564 | OSSE-LIGN | JDQ | 2003-03-11 |
| 161095 | 1598118611 | K022908 | POSTERIOR CABLE SCREW | MNI | 2004-01-22 |
| 161095 | 1705716570 | K022726 | STAYFUSE GT-IP | HWC | 2002-09-06 |
| 302173 | 1042152091 | K003496 | CANNULATED SCREW SYSTEM | HTN | 2001-02-08 |
| 161095 | 1258327120 | K003496 | CANNULATED SCREW SYSTEM | HTN | 2001-02-08 |
| 302173 | 1277242358 | K002110 | SPL CRIMP SYSTEM | JDQ | 2000-10-06 |
| 161095 | 1625671713 | K002110 | SPL CRIMP SYSTEM | JDQ | 2000-10-06 |
| 302173 | 1120641528 | K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 | JDQ | 2000-08-31 |
| 161095 | 2052368188 | K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 | JDQ | 2000-08-31 |
| 302173 | 1514350178 | K000734 | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 | KTT | 2000-05-05 |
| 161095 | 1914132144 | K000734 | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 | KTT | 2000-05-05 |
| 161095 | 1083630162 | ||||
| 161095 | 1109728158 | ||||
| 161095 | 1192034164 | ||||
| 161095 | 1198160282 | ||||
| 161095 | 1221873685 | ||||
| 161095 | 1278181196 | ||||
| 161095 | 1300532558 | ||||
| 161095 | 1302570845 | ||||
| 161095 | 1310378226 | ||||
| 161095 | 1321148798 | ||||
| 161095 | 1389113647 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JDQ | 22 | 2020-10-28 |
| KWQ | 14 | 2023-06-20 |
| NKB | 12 | 2019-11-26 |
| MQV | 8 | 2014-10-17 |
| HRS | 6 | 2022-04-28 |
| MAX | 6 | 2019-12-20 |
| OUR | 6 | 2015-08-05 |
| KWP | 5 | 2015-04-28 |
| HWC | 5 | 2010-10-20 |
| KTT | 4 | 2015-12-30 |
| HTN | 4 | 2001-02-08 |
| ODP | 3 | 2017-05-23 |
| MQP | 3 | 2013-12-24 |
| NKG | 2 | 2017-08-18 |
| GEI | 2 | 2013-05-10 |
| OVE | 1 | 2017-06-28 |
| NQW | 1 | 2016-01-21 |
| PDQ | 1 | 2015-03-05 |
| MNH | 1 | 2010-08-10 |
| GXZ | 1 | 2008-06-06 |
| MNI | 1 | 2004-01-22 |
| HSB | 1 | 1999-04-01 |
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Pioneer Surgical Technology, Inc.,
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Pioneer Surgical Technology, Inc.
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc., DBA RTI Surgical
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc.
Pioneer Surgical Technology, Inc.
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC.
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER SURGICAL TECHNOLOGY, INC
PIONEER SURGICAL TECHNOLOGY, INC.
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