KLS Martin Drill-Free MMF Screw
KLS-Martin L.P.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1057946 | 1000525271 | KLS-Martin L.P. | 1 | Y | 2026-01-01 | 11201 Saint Johns Industrial Pkwy S Jacksonville FL US 32246 |
| 1057946 | 1000525271 | KLS Martin LP | 1 | Y | 2020-04-25 | 11201 Saint Johns Industrial Pkwy S Jacksonville FL US 32246 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00888118131782 | LEVEL ONE EXTREMITY - SIZER, RECOS, FOR 26-166-60-XX AND 26-166-65-XX, TITANIUM | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118131799 | LEVEL ONE EXTREMITY - SIZER, RECOS, FOR 26-166-70-XX AND 26-166-75-XX, TITANIUM | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118144928 | LEVEL ONE EXTREMITY - MANIPULATOR, HOOK, IXOS | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118145284 | PURE PECTUS - STABILIZER, SMALL, TI-6AL-4V | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118145291 | PURE PECTUS - STABILIZER, LARGE, TI-6AL-4V | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118150240 | PURE PECTUS - CASE, BASE, REMOVAL INSTRUMENTS | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118150257 | PURE PECTUS - CASE, LID, REMOVAL INSTRUMENTS | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| 00888118150264 | PURE PECTUS - PULLOUT TRAY, REMOVAL INSTRUMENTS | +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 321644 | 1520352829 | K994154 | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES | JEY | 2000-02-15 |
| 9085 | 2028971916 | K994154 | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES | JEY | 2000-02-15 |
| 9085 | 1280402580 | K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | NEI | 2001-07-27 |
| 321644 | 1430557983 | K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | NEI | 2001-07-27 |
| 321644 | 1132233490 | K983809 | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR | MQN | 1999-01-26 |
| 9085 | 1554127931 | K983809 | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR | MQN | 1999-01-26 |
| 9085 | 1777976383 | K983515 | KLS INTRAORAL VERTICAL DISTRACTOR | MQN | 1998-11-30 |
| 321644 | 1195811518 | K980760 | KLS-MARTIN MMF SCREW | DZL | 1999-12-21 |
| 9085 | 2065519316 | K980760 | KLS-MARTIN MMF SCREW | DZL | 1999-12-21 |
| 9085 | 1058150648 | K973275 | KLS-MARTIN INTRAORAL DISTRACTOR | MQN | 1997-11-20 |
| 9085 | 1007393380 | K972047 | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE | MQN | 1997-06-24 |
| 321644 | 1578436946 | K972047 | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE | MQN | 1997-06-24 |
| 321644 | 1964557538 | K971297 | CENTRE-DRIVE DRILL-FREE SCREW | HRS | 1997-05-08 |
| 9085 | 2054103649 | K971297 | CENTRE-DRIVE DRILL-FREE SCREW | HRS | 1997-05-08 |
| 9085 | 1480603341 | K950045 | KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM | JEY | 1995-03-23 |
| 321644 | 1374266622 | K944565 | KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) | JEY | 1994-10-18 |
| 9085 | 1684420267 | K944565 | KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) | JEY | 1994-10-18 |
| 9085 | 1947404192 | K944561 | MICRO OSTEOSYNTHESIS SYSTEM (1.0) | JEY | 1994-10-18 |
| 321644 | 1997075225 | K944561 | MICRO OSTEOSYNTHESIS SYSTEM (1.0) | JEY | 1994-10-18 |
| 321644 | 1364425827 | K943348 | KLS CHIN PLATE SYSTEM | JEY | 1994-10-04 |
| 9085 | 2012760661 | K943348 | KLS CHIN PLATE SYSTEM | JEY | 1994-10-04 |
| 321644 | 1242986598 | K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM | JEY | 1994-10-04 |
| 9085 | 1451444640 | K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM | JEY | 1994-10-04 |
| 321644 | 1669663593 | K254162 | KLS Martin Ixos System | HRS | 2026-02-20 |
| 321644 | 2060849604 | K253660 | KLS Martin Pure Pectus System | HRS | 2026-02-20 |
| 321644 | 1081073352 | K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | GXN | 2025-11-10 |
| 321644 | 1367058578 | K250988 | KLS Martin Pure Pectus System | HRS | 2025-12-11 |
| 321644 | 1411046495 | K250865 | KLS Martin IPS Forearm System | HRS | 2025-11-14 |
| 321644 | 1071228833 | K250620 | KLS Martin Ixos System | HRS | 2025-08-15 |
| 321644 | 1429800169 | K241018 | KLS Martin Orthopedic Implants - MR Conditional | HRS | 2024-07-12 |
| 321644 | 1628858691 | K233721 | KLS Martin Drill-Free MMF Screw | DZL | 2024-09-17 |
| 321644 | 1428246309 | K230211 | CranioXpand | PBJ | 2023-11-21 |
| 321644 | 1997791043 | K222624 | KLS Martin LINOS Wrist System | HRS | 2023-05-25 |
| 321644 | 1454895887 | K222397 | KLS Martin Level One Rib Fixation System | HRS | 2023-03-29 |
| 321644 | 1781325043 | K221938 | KLS Martin Pure Pectus System | HRS | 2023-03-28 |
| 321644 | 1259617054 | K220050 | KLS Martin IPS Distraction | MQN | 2022-08-11 |
| 321644 | 1280912359 | K210741 | KLS Martin Neuro Rongeurs | HAE | 2022-06-03 |
| 321644 | 1137985135 | K210731 | KLS Martin Individual Patient Solutions | JEY | 2022-07-18 |
| 321644 | 1308281968 | K210228 | KLS Martin IPS Preprosthetic | ELE | 2022-07-08 |
| 321644 | 1778166530 | K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | PPT | 2020-08-31 |
| 321644 | 1537872368 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | PBF | 2020-03-11 |
| 9085 | 2009337901 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | PBF | 2020-03-11 |
| 321644 | 1037743947 | K191028 | KLS Martin Individual Patient Solutions | JEY | 2019-11-22 |
| 9085 | 1422244342 | K191028 | KLS Martin Individual Patient Solutions | JEY | 2019-11-22 |
| 9085 | 1361405441 | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | PPT | 2019-07-26 |
| 321644 | 1641279575 | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | PPT | 2019-07-26 |
| 321644 | 1399826931 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | DZJ | 2019-03-11 |
| 9085 | 1560416355 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | DZJ | 2019-03-11 |
| 9085 | 1548685570 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | DZJ | 2018-09-13 |
| 321644 | 1857294681 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | DZJ | 2018-09-13 |
| 9085 | 1449671304 | K180962 | KLS Martin Individual Patient Solutions | JEY | 2018-08-13 |
| 321644 | 1906968029 | K180962 | KLS Martin Individual Patient Solutions | JEY | 2018-08-13 |
| 321644 | 1413055480 | K173320 | KLS Martin L1 MMF System | JEY | 2018-02-23 |
| 9085 | 1498092791 | K173320 | KLS Martin L1 MMF System | JEY | 2018-02-23 |
| 9085 | 1847539023 | K170124 | Level One Hand Plating System | HRS | 2017-03-09 |
| 321644 | 1972722177 | K170124 | Level One Hand Plating System | HRS | 2017-03-09 |
| 9085 | 1323597521 | K163579 | KLS Martin Individual Patient Solutions | JEY | 2017-11-21 |
| 321644 | 2024406918 | K163579 | KLS Martin Individual Patient Solutions | JEY | 2017-11-21 |
| 321644 | 1296358460 | K163315 | Internal Distraction - Sterile | PBJ | 2017-05-05 |
| 9085 | 1571456738 | K163315 | Internal Distraction - Sterile | PBJ | 2017-05-05 |
| 321644 | 1169742175 | K161470 | Internal Distraction - Sterile | MQN | 2016-12-01 |
| 9085 | 1879210967 | K161470 | Internal Distraction - Sterile | MQN | 2016-12-01 |
| 9085 | 1348069675 | K161259 | KLS Martin Cannulated Headless Screws | HWC | 2016-12-19 |
| 321644 | 1939876838 | K161259 | KLS Martin Cannulated Headless Screws | HWC | 2016-12-19 |
| 321644 | 1252639001 | K153482 | KLS Martin Thoracic Plating System | HRS | 2016-04-06 |
| 9085 | 1869943358 | K153482 | KLS Martin Thoracic Plating System | HRS | 2016-04-06 |
| 9085 | 1763543656 | K151983 | KLS Martin LSS Plating System | JDQ | 2016-04-06 |
| 321644 | 1899417699 | K151983 | KLS Martin LSS Plating System | JDQ | 2016-04-06 |
| 321644 | 1397439550 | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | GXN | 2015-11-09 |
| 9085 | 1838620369 | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | GXN | 2015-11-09 |
| 9085 | 1410076970 | K150771 | RxG Distraction System | PBJ | 2015-08-27 |
| 321644 | 1216565235 | K141489 | LINOS MOH HAND PLATING SYSTEM | HRS | 2014-07-24 |
| 9085 | 1901184986 | K141489 | LINOS MOH HAND PLATING SYSTEM | HRS | 2014-07-24 |
| 321644 | 1066275630 | K133304 | RXG DISTRACTION SYSTEM | JEY | 2014-05-15 |
| 9085 | 1719431475 | K133304 | RXG DISTRACTION SYSTEM | JEY | 2014-05-15 |
| 9085 | 1769339889 | K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | GXR | 2013-09-30 |
| 9085 | 1991307783 | K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | GEI | 2013-08-23 |
| 321644 | 1083216510 | K122860 | KLS MARTIN RECON TALON | HRS | 2012-11-14 |
| 9085 | 1331286008 | K122860 | KLS MARTIN RECON TALON | HRS | 2012-11-14 |
| 321644 | 1160010995 | K121606 | RESORB-X G | GWO | 2013-01-17 |
| 9085 | 2048557656 | K121606 | RESORB-X G | GWO | 2013-01-17 |
| 321644 | 1212121631 | K112064 | RESORB X-G | JEY | 2012-03-23 |
| 9085 | 1749009206 | K112064 | RESORB X-G | JEY | 2012-03-23 |
| 321644 | 2026186389 | K083432 | DRILL FREE MMF SCREW | DZL | 2009-03-31 |
| 9085 | 2065642467 | K083432 | DRILL FREE MMF SCREW | DZL | 2009-03-31 |
| 9085 | 1655366294 | K082505 | KLS MARTIN ELECTROSURGICAL INSTRUMENTS | GEI | 2009-06-12 |
| 9085 | 1184032060 | K080862 | SONICWELD RX (RESORB-X) | JEY | 2008-07-21 |
| 321644 | 1793995780 | K080862 | SONICWELD RX (RESORB-X) | JEY | 2008-07-21 |
| 321644 | 1500753125 | K072764 | KLS MARTIN XTERNAL FIXATOR | MQN | 2007-12-20 |
| 9085 | 1610550908 | K072764 | KLS MARTIN XTERNAL FIXATOR | MQN | 2007-12-20 |
| 9085 | 1883599745 | K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | GXN | 2007-12-19 |
| 321644 | 1974264100 | K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | GXN | 2007-12-19 |
| 9085 | 1023977867 | K070169 | KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE | HRS | 2007-03-26 |
| 321644 | 1835327222 | K070169 | KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE | HRS | 2007-03-26 |
| 9085 | 1507785311 | K062857 | KLS MARTIN QUICK DISC | GXN | 2006-11-22 |
| 321644 | 1221802915 | K062570 | PATIENT CONTOURED MESH (PCM) | GXN | 2006-10-31 |
| 9085 | 1228125213 | K062570 | PATIENT CONTOURED MESH (PCM) | GXN | 2006-10-31 |
| 9085 | 1595007942 | K061507 | SONICWELD RX ENDOBROW FIXATION | JEY | 2006-09-21 |
| 9085 | 1838341217 | K061271 | ERCH ARCH BAR, MODEL 38-690-00 | DYX | 2006-06-30 |
| 321644 | 1522758036 | K060177 | KLS MARTIN RIGID FIXATION - STERILE | JEY | 2006-04-18 |
| 9085 | 1989720236 | K060177 | KLS MARTIN RIGID FIXATION - STERILE | JEY | 2006-04-18 |
| 9085 | 1369972930 | K060097 | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 | GZT | 2006-02-27 |
| 9085 | 2028308266 | K051236 | RESORB-X SF | JEY | 2005-08-22 |
| 9085 | 1680426355 | K051165 | KLS MARTIN STERNAL TALON | HRS | 2006-09-07 |
| 9085 | 1673780593 | K050051 | ARMAND ENDOSCOPE HOLDER | GCJ | 2005-05-16 |
| 321644 | 1281932117 | K042573 | KLS MARTIN DRILL-FREE MMF SCREW | DZL | 2004-10-18 |
| 9085 | 2056070806 | K042573 | KLS MARTIN DRILL-FREE MMF SCREW | DZL | 2004-10-18 |
| 9085 | 1291889169 | K042066 | KLSA MARTIN HAND DISTRACTOR | JEC | 2004-08-25 |
| 321644 | 1465120137 | K042066 | KLSA MARTIN HAND DISTRACTOR | JEC | 2004-08-25 |
| 321644 | 1006145794 | K040891 | KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) | DZE | 2004-05-28 |
| 9085 | 1717706442 | K040891 | KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) | DZE | 2004-05-28 |
| 9085 | 1290610767 | K040598 | KLS MARTIN HAND PLATING SYSTEM | HRS | 2004-05-13 |
| 321644 | 1632965136 | K040598 | KLS MARTIN HAND PLATING SYSTEM | HRS | 2004-05-13 |
| 321644 | 1824782767 | K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | MQN | 2004-02-27 |
| 9085 | 1969594133 | K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | MQN | 2004-02-27 |
| 9085 | 1050316138 | K033483 | KLS-MARTIN ORTHO ANCHORAGE SYSTEM | DZE | 2004-01-15 |
| 321644 | 1202530249 | K033483 | KLS-MARTIN ORTHO ANCHORAGE SYSTEM | DZE | 2004-01-15 |
| 9085 | 1265122465 | K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | MQN | 2003-10-29 |
| 321644 | 2044797394 | K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | MQN | 2003-10-29 |
| 321644 | 1514045577 | K032413 | KLS-MARTIN STERNAL PLATING SYSTEM | HRS | 2003-10-10 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JEY | 32 | 2022-07-18 |
| HRS | 26 | 2026-02-20 |
| MQN | 20 | 2022-08-11 |
| GXN | 8 | 2025-11-10 |
| DZL | 7 | 2024-09-17 |
| PBJ | 4 | 2023-11-21 |
| DZJ | 4 | 2019-03-11 |
| DZE | 4 | 2004-05-28 |
| PPT | 3 | 2020-08-31 |
| PBF | 2 | 2020-03-11 |
| HWC | 2 | 2016-12-19 |
| JDQ | 2 | 2016-04-06 |
| GEI | 2 | 2013-08-23 |
| GWO | 2 | 2013-01-17 |
| JEC | 2 | 2004-08-25 |
| NEI | 2 | 2001-07-27 |
| ELE | 1 | 2022-07-08 |
| HAE | 1 | 2022-06-03 |
| GXR | 1 | 2013-09-30 |
| DYX | 1 | 2006-06-30 |
| GZT | 1 | 2006-02-27 |
| GCJ | 1 | 2005-05-16 |
KLS-Martin L.P.
KLS-Martin L.P.
KLS-Martin L.P.
KLS-Martin L.P.
KLS-Martin L.P.
KLS-Martin L.P.
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KLS-MARTIN L.P.
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KLS-Martin L.P.
KLS-Martin L.P.
KLS-Martin L.P.
KLS-Martin L.P.
KLS Martin LP
KLS Martin LP
KLS Martin LP
KLS MARTIN LP
KLS MARTIN LP
KLS MARTIN LP
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
KLS-MARTIN L.P.
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KLS-MARTIN L.P.
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