MedTorque - DVR, FXD, AXIAL HDL, JWLR, AO PULL CPLG, RR SPIN CAP, CANN, BLACK
2025-03-05
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1221763 | 1221763 | ARCH Medical Solutions - Seabrook | 1 | N | 2026-01-01 | 15 WOODWORKERS WAY SEABROOK NH US 03874 |
| 1424434 | 3002795782 | ARCH Medical Solutions - Elmhurst | 1 | N | 2026-01-01 | 612 W Lamont Rd Elmhurst IL US 60126 |
| 2029005 | 1000160570 | ARCH Medical Solutions - Escondido LLC | 1 | N | 2026-01-01 | 950 Borra Place ESCONDIDO CA US 92029 |
| 3006791286 | 3006791286 | ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS | 1 | N | 2026-01-01 | 3063 B Philmont Ave. Huntingdon Valley PA US 19006 |
| 3009971621 | 3009971621 | ARCH Medical Solutions - Warsaw | 1 | N | 2026-01-01 | 2070 N Cessna Rd Warsaw IN US 46582 |
| 3009973505 | 3009973505 | ARCH Medical Solutions - Memphis | 1 | N | 2026-01-01 | 7580 BARTLETT CORPORATE DR BARTLETT TN US 38133 |
| 3010123206 | 3010123206 | ARCH Medical Solutions - Olive Branch | 1 | N | 2026-01-01 | 7221 Old Craft Cv Olive Branch MS US 38654 |
| 3016438694 | 3016438694 | ARCH Medical Solutions - Memphis | 1 | N | 2026-01-01 | 255 Kirby Dr Lexington TN US 38351 |
| 3009923627 | 3009923627 | Arch Medical Solutions - Elkhart | 1 | N | 2020-04-25 | 2921 Lavanture Pl Elkhart IN US 46514 |
| 3010041662 | 3010041662 | Arch Medical Solutions-Sparta, LLC | 1 | N | 2020-04-25 | 15 Wilson Dr Sparta NJ US 07871 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00817247020056 | MedTorque - Fixed Driver / Slim T-Handle / ZSJ Hall Coupling / Blue | 12623584370 | aschultz@medtorque.com |
| 00817247021725 | MedTorque - Fixed Driver / Slim Standard Axial Handle / ZSJ-Hall Coupling / Cannulated / Black | 12623584370 | april.schultz@archgp.com |
| 00817247023477 | MedTorque - AFX STRAIGHT HANDLE, Z/H | 12623584370 | april.schultz@archgp.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 154055 | 1581135407 | P100012 | NUVASIVE PCM CERVICAL DISC SYSTEM | MJO | 2012-10-26 |
| 145995 | 1710729232 | P100003 | SECURE-C ARTIFICIAL CERVICAL DISC | MJO | 2012-09-28 |
| 56531 | 1122913737 | P060023 | BRYAN CERVICAL DISC PROSTHESIS | MJO | 2009-05-12 |
| 56531 | 1587230811 | K984578 | SYNERGY D2 SPINAL IMPLANTS | MNI | 1999-03-23 |
| 25889 | 1932086589 | K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | DZE | 1998-09-22 |
| 56531 | 1337370130 | K974749 | SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS | MNH | 1998-03-13 |
| 56531 | 1822154991 | K950709 | SYNERGY TI ANTERIOR SPINAL SYSTEM | KWQ | 1995-10-25 |
| 56531 | 1040700242 | K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | MNH | 1997-01-16 |
| 56531 | 1106960261 | K940631 | CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM | MNH | 1995-07-13 |
| 56531 | 1744189545 | K181820 | Medline Unite Mini Plates and Screws | HRS | 2018-11-01 |
| 145995 | 1331618957 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | NKB | 2018-09-18 |
| 145995 | 1899329392 | K180690 | Navigation Instruments | OLO | 2018-06-25 |
| 145995 | 1381220036 | K180210 | CREO® Stabilization System | NKB | 2018-04-02 |
| 154055 | 1152554236 | K173814 | DeGen Medical E3 MIS Pedicle Screw System | NKB | 2018-01-29 |
| 145995 | 1568488324 | K173166 | ANTHEM Fracture System | HRS | 2017-11-13 |
| 145995 | 1946487860 | K171651 | EXCELSIUS GPS | OLO | 2017-08-16 |
| 56531 | 1440031877 | K162829 | Medline UNITE® Ankle Fracture Plating System | HRS | 2016-12-09 |
| 25889 | 1466987006 | K160154 | ALTA Anterior Cervical Interbody Spacer | ODP | 2016-05-13 |
| 25889 | 1313863626 | K153446 | OLYMPIC Posterior Spinal Fixation System | OSH | 2016-04-08 |
| 145995 | 1619783728 | K153203 | Navigation Instruments | OLO | 2016-02-03 |
| 56531 | 2033264246 | K151235 | Medline Foot Plates and Screws | HRS | 2015-08-06 |
| 145995 | 1365543980 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | NKG | 2015-06-04 |
| 152767 | 1240411827 | K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | MBH | 2013-11-26 |
| 145995 | 1320371337 | K132559 | MONUMENT SPACERS | OVD | 2013-12-30 |
| 152767 | 2064389807 | K132426 | SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS | LBH | 2014-02-14 |
| 145995 | 1406293031 | K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | MBI | 2013-06-20 |
| 145995 | 1653830415 | K124058 | CREO STABILIZATION SYSTEM | OSH | 2013-05-13 |
| 145995 | 1460549477 | K123913 | LATIS SPACER | MAX | 2013-05-13 |
| 25889 | 1280612352 | K123861 | AIDI DENTAL IMPLANT SYSTEM | DZE | 2013-12-12 |
| 152767 | 1397772036 | K123604 | ABG III MONOLITHIC HIP STEM | MAY | 2013-08-16 |
| 152767 | 1876980764 | K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE | MBH | 2013-05-03 |
| 145995 | 1047590244 | K122226 | REVERE STABILIZATION SYSTEM | NKB | 2012-10-01 |
| 145995 | 1225530601 | K121922 | BEACON STABILIZATION SYSTEM | NKB | 2012-07-26 |
| 145995 | 1661079257 | K121107 | FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) | MQP | 2012-07-03 |
| 145995 | 1028165002 | K121049 | UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2012-06-27 |
| 25889 | 1707751795 | K120875 | B&W DENTAL IMPLANT SYSTEM | DZE | 2012-09-07 |
| 25889 | 1832155924 | K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM | NHA | 2012-11-08 |
| 56531 | 2003007496 | K120359 | ORTHOLOC 3DI HALLUX SYSTEM | HRS | 2012-05-03 |
| 145995 | 1493870551 | K120101 | INDEPENDENCE SPACER | OVD | 2012-03-27 |
| 145995 | 1984941594 | K120092 | PLYMOUTH THORACOLUMBAR PLATE SYSTEM | KWQ | 2012-04-13 |
| 56531 | 1043340286 | K113593 | NEXTGEN ALTIUS OCT SYSTEM | KWP | 2012-04-17 |
| 56531 | 1557758508 | K113528 | CLYDESDALE(R) SPINAL SYSTEM | MAX | 2011-12-20 |
| 145995 | 1723899779 | K113447 | RISE SPACER | MAX | 2012-01-26 |
| 145995 | 1592827327 | K113395 | REVERE 4.5 STABILIZATION SYSTEM | NKB | 2012-06-14 |
| 56531 | 1070918318 | K113014 | CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS | HRS | 2012-01-31 |
| 145995 | 2010159903 | K112756 | FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS | MQP | 2011-10-07 |
| 145995 | 1111985315 | K112028 | SI-LOK SACROILIAC JOINT FIXATION SYSTEM | HWC | 2011-12-09 |
| 145995 | 1849399175 | K111479 | REVERE CROSSTOP | NKB | 2011-08-17 |
| 145995 | 1788665390 | K111449 | REVOLVE ADDITIONAL IMPLANTS | NKB | 2011-08-17 |
| 56531 | 1987850326 | K111432 | EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS | HRS | 2011-08-19 |
| 56531 | 1117711012 | K111264 | CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM | ODP | 2011-10-12 |
| 145995 | 1401902458 | K110998 | AFFIRM (TM) VCF SYSTEM | NDN | 2011-10-25 |
| 145995 | 1185831809 | K110963 | ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM | KWP | 2011-05-05 |
| 56531 | 1445031806 | K110963 | ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM | KWP | 2011-05-05 |
| 56531 | 1277568904 | K110360 | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | HSN | 2011-12-16 |
| 145995 | 1071404401 | K103382 | INTERCONTINENTAL PLATE-SPACER | OVD | 2011-05-20 |
| 56531 | 1428115399 | K103111 | FORZA SPACER SYSTEM | MAX | 2011-03-23 |
| 145995 | 1119835378 | K103072 | REVERE SACRAL PLATES | NKB | 2011-03-17 |
| 56531 | 1583943613 | K102352 | EVOLVE EPS ORTHOLOC | HRS | 2010-12-02 |
| 145995 | 2001415524 | K102293 | CALIBER SPACER | MAX | 2011-01-05 |
| 56531 | 1790763466 | K102195 | SP-FIX SPINOUS PROCESS FIXATION PLATE | KWP | 2011-01-19 |
| 25889 | 1977010236 | K101755 | AIDI DENTAL IMPLANT SYSTEM | DZE | 2010-11-22 |
| 56531 | 1324355780 | K100886 | INBONE II TOTAL ANKLE REPLACEMENT | HSN | 2010-08-26 |
| 56531 | 1566422703 | K100137 | SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES | KTT | 2010-06-10 |
| 56531 | 1514700697 | K094042 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | 2010-06-30 |
| 145995 | 1511429914 | K093294 | REVERE STABILIZATION SYSTEM | NKB | 2010-02-17 |
| 145995 | 1073501408 | K093242 | PATRIOT TRANSCONTINENTAL LLIF SPACER | MAX | 2009-12-23 |
| 25889 | 1418806296 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | NHA | 2009-11-30 |
| 145995 | 1631967324 | K092108 | TRUSS THORACOLUMBAR PLATE SYSTEM | KWQ | 2009-08-13 |
| 145995 | 1483967496 | K091782 | REVERE 6.35 STABILIZATION SYSTEM | NKB | 2009-08-13 |
| 145995 | 2045613964 | K090952 | ZYFUSE FACET FIXATION SYSTEM | MRW | 2009-07-14 |
| 56531 | 1641622114 | K090857 | VALOR ANKLE FUSION NAIL SYSTEM | HSB | 2009-07-14 |
| 56531 | 1651052813 | K090565 | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM | KWP | 2009-06-30 |
| 145995 | 1901159159 | K090565 | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM | KWP | 2009-06-30 |
| 145995 | 1017721055 | K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM | HSB | 2009-03-11 |
| 145995 | 1452452510 | K083442 | CORRIDOR FIXATION SYSTEM | MRW | 2009-02-06 |
| 145995 | 1105744467 | K083389 | COALITION SPACER | OVE | 2009-03-26 |
| 145995 | 1047628453 | K082252 | INDEPENDENCE SPACER | OVD | 2008-11-05 |
| 56531 | 1146508206 | K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | MAX | 2008-09-04 |
| 145995 | 1161912160 | K081906 | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | KWP | 2008-11-14 |
| 25889 | 1367501248 | K081806 | IDI IMPLANT SYSTEM | DZE | 2008-11-07 |
| 56531 | 2004720728 | K081684 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | 2008-09-15 |
| 145995 | 1140939660 | K081391 | VIP ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-07-03 |
| 145995 | 1417572865 | K081195 | REVERE UNIPLANAR SCREWS | NKB | 2008-05-28 |
| 145995 | 1232173514 | K080664 | RELIEVE LAMINOPLASTY FIXATION SYSTEM | NQW | 2008-07-25 |
| 56531 | 2058269694 | K080133 | MOUNTABLE ENDOSCOPIC BLADE | EMF | 2008-03-13 |
| 56531 | 1879052525 | K080071 | SIDEKICK RAIL FIXATOR | KTT | 2008-02-07 |
| 145995 | 1701969279 | K073439 | TRANSITION STABILIZATION SYSTEM | NQP | 2009-02-20 |
| 56531 | 1669550716 | K073285 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | 2008-05-15 |
| 145995 | 1717496484 | K073172 | BEACON STABILIZATION SYSTEM | NKB | 2007-12-13 |
| 145995 | 1947516881 | K072991 | PATRIOT SPACERS: COLONIAL ACDF | ODP | 2008-01-18 |
| 145995 | 1774921055 | K072970 | PATRIOT SPACERS | MAX | 2008-01-18 |
| 25889 | 2000872010 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | NHA | 2007-12-20 |
| 56531 | 1391880714 | K071377 | POLARIS BE RODS | KWP | 2007-08-06 |
| 56531 | 1612137219 | K071033 | T2 XVBR SPINAL SYSTEM | MQP | 2007-08-14 |
| 56531 | 1318882697 | K070775 | MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2007-04-19 |
| 145995 | 1389197286 | K070775 | MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2007-04-19 |
| 145995 | 1331370262 | K062836 | CITADEL ANTERIOR LUMBAR PLATE SYSTEM | KWQ | 2006-12-19 |
| 145995 | 1790009663 | K062407 | GATEWAY THORACOLUMBAR PLATE SYSTEM | KWQ | 2006-09-06 |
| 145995 | 1867498696 | K061380 | RETAIN RADIOLUCENT SPACER | MQP | 2006-06-08 |
| 145995 | 1262728542 | K061202 | REVERE STABILIZATION SYSTEM | NKB | 2006-07-20 |
| 25889 | 1328430228 | K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) | NHA | 2005-10-13 |
| 145995 | 1946825490 | K052069 | PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES | KWP | 2005-08-17 |
| 56531 | 2058400157 | K052005 | R&R EXTERNAL FIXATION SYSTEM | KTT | 2005-09-06 |
| 56531 | 2070122115 | K051246 | CONSTRUX MINI PEEK VBR SYSTEM | MQP | 2005-06-14 |
| 56531 | 1753766315 | K051023 | TOPEZ TOTAL ANKLE REPLACEMENT | HSN | 2005-11-15 |
| 145995 | 1968885467 | K050391 | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | KWP | 2005-07-21 |
| 56531 | 1592728484 | K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | NQW | 2005-02-18 |
| 56531 | 1174488700 | K043174 | STEALTH FUSION SYSTEM, MODEL RR 1000 | KTT | 2005-02-07 |
| 145995 | 1585133718 | K042953 | MODIFICATION TO PROTEX STABILIZATION SYSTEM | NKB | 2004-11-22 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NKB | 16 | 2018-09-18 |
| DZE | 16 | 2013-12-12 |
| KWP | 12 | 2012-04-17 |
| KWQ | 10 | 2012-06-27 |
| HRS | 9 | 2018-11-01 |
| NHA | 9 | 2012-11-08 |
| MAX | 8 | 2013-05-13 |
| MQP | 7 | 2012-07-03 |
| ODP | 4 | 2016-05-13 |
| OVD | 4 | 2013-12-30 |
| KTT | 4 | 2010-06-10 |
| MNH | 4 | 2004-05-20 |
| OLO | 3 | 2018-06-25 |
| OSH | 3 | 2016-04-08 |
| HSN | 3 | 2011-12-16 |
| OVE | 3 | 2010-06-30 |
| MBH | 2 | 2013-11-26 |
| MJO | 2 | 2012-10-26 |
| MRW | 2 | 2009-07-14 |
| HSB | 2 | 2009-07-14 |
| NQW | 2 | 2008-07-25 |
| JEY | 2 | 2001-09-18 |
| MNI | 2 | 2001-06-06 |
| NKG | 1 | 2015-06-04 |
| LBH | 1 | 2014-02-14 |
| MAY | 1 | 2013-08-16 |
| MBI | 1 | 2013-06-20 |
| MJO | 1 | 2012-09-28 |
| HWC | 1 | 2011-12-09 |
| NDN | 1 | 2011-10-25 |
| NQP | 1 | 2009-02-20 |
| EMF | 1 | 2008-03-13 |
2025-03-05
2024-11-08
2024-11-08
2024-11-08
2024-03-19
2023-10-17