Company ยท US
KLS-Martin L.P.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
81510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JEY | Plate, Bone | 19 |
| HRS | Plate, Fixation, Bone | 18 |
| MQN | External Mandibular Fixator And/Or Distractor | 13 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 5 |
| DZL | Screw, Fixation, Intraosseous | 4 |
| PBJ | Cranial Distraction System | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| PPT | Cranial Surgical Planning And Instrument Guides | 2 |
| DYX | Lock, Wire, And Ligature, Intraoral | 1 |
| ELE | Implant, Subperiosteal | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 |
| HAE | Rongeur, Manual | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| JDQ | Cerclage, Fixation | 1 |
| JEC | Component, Traction, Invasive | 1 |
| NEI | Prosthesis, Condyle, Mandibular, Temporary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 2026 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Soluti KLS-Martin L.P. | JEY |
| Feb 20, 2026 | K254162 | KLS Martin Ixos System KLS Martin L.P. | HRS |
| Feb 20, 2026 | K253660 | KLS Martin Pure Pectus System KLS-Martin L.P. | HRS |
| Dec 11, 2025 | K250988 | KLS Martin Pure Pectus System KLS-Martin L.P. | HRS |
| Nov 14, 2025 | K250865 | KLS Martin IPS Forearm System KLS-Martin L.P. | HRS |
| Nov 10, 2025 | K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Mart KLS-Martin L.P. | GXN |
| Aug 15, 2025 | K250620 | KLS Martin Ixos System KLS Martin L.P. | HRS |
| Sep 17, 2024 | K233721 | KLS Martin Drill-Free MMF Screw KLS-Martin L.P. | DZL |
| Aug 16, 2024 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) KLS-Martin L.P. | JEY |
| Jul 12, 2024 | K241018 | KLS Martin Orthopedic Implants - MR Conditional KLS-Martin L.P. | HRS |
| Nov 21, 2023 | K230211 | CranioXpand KLS-Martin L.P. | PBJ |
| May 25, 2023 | K222624 | KLS Martin LINOS Wrist System KLS-Martin L.P. | HRS |
| Mar 29, 2023 | K222397 | KLS Martin Level One Rib Fixation System KLS-Martin L.P. | HRS |
| Mar 28, 2023 | K221938 | KLS Martin Pure Pectus System KLS Martin L.P. | HRS |
| Aug 11, 2022 | K220050 | KLS Martin IPS Distraction KLS Martin L.P. | MQN |
| Jul 18, 2022 | K210731 | KLS Martin Individual Patient Solutions KLS-Martin L.P. | JEY |
| Jul 8, 2022 | K210228 | KLS Martin IPS Preprosthetic KLS-Martin L.P. | ELE |
| Jun 3, 2022 | K210741 | KLS Martin Neuro Rongeurs KLS-Martin L.P. | HAE |
| Aug 31, 2020 | K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | PPT |
| Mar 11, 2020 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | PBF |
| Nov 22, 2019 | K191028 | KLS Martin Individual Patient Solutions KLS-Martin L.P. | JEY |
| Jul 26, 2019 | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | PPT |
| Apr 11, 2019 | K183526 | Codman Electrosurgical Generator, Foot Pedal Kls Martin GmbH + Co. KG, DE | GEI |
| Mar 11, 2019 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | DZJ |
| Sep 13, 2018 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | DZJ |
| Aug 13, 2018 | K180962 | KLS Martin Individual Patient Solutions KLS-Martin L.P. | JEY |
| Feb 23, 2018 | K173320 | KLS Martin L1 MMF System KLS Martin L.P. | JEY |
| Nov 21, 2017 | K163579 | KLS Martin Individual Patient Solutions KLS Martin L.P. | JEY |
| May 5, 2017 | K163315 | Internal Distraction - Sterile KLS Martin L.P. | PBJ |
| Mar 9, 2017 | K170124 | Level One Hand Plating System KLS Martin L.P. | HRS |
| Dec 19, 2016 | K161259 | KLS Martin Cannulated Headless Screws KLS Martin L.P. | HWC |
| Dec 1, 2016 | K161470 | Internal Distraction - Sterile KLS Martin L.P. | MQN |
| Apr 6, 2016 | K153482 | KLS Martin Thoracic Plating System KLS-Martin L.P. | HRS |
| Apr 6, 2016 | K151983 | KLS Martin LSS Plating System KLS Martin L.P. | JDQ |
| Nov 9, 2015 | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) KLS Martin L.P. | GXN |
| Aug 27, 2015 | K150771 | RxG Distraction System KLS Martin L.P. | PBJ |
| Jul 24, 2014 | K141489 | LINOS MOH HAND PLATING SYSTEM KLS Martin L.P. | HRS |
| May 15, 2014 | K133304 | RXG DISTRACTION SYSTEM KLS-Martin L.P. | JEY |
| Jan 17, 2013 | K121606 | RESORB-X G KLS-Martin L.P. | GWO |
| Nov 14, 2012 | K122860 | KLS MARTIN RECON TALON KLS Martin L.P. | HRS |
| Mar 23, 2012 | K112064 | RESORB X-G KLS-Martin L.P. | JEY |
| Mar 31, 2009 | K083432 | DRILL FREE MMF SCREW KLS Martin L.P. | DZL |
| Jul 29, 2008 | K081678 | CONMED BEAMER SYSTEM C600 Kls Martin GmbH + Co. KG, DE | GEI |
| Jul 21, 2008 | K080862 | SONICWELD RX (RESORB-X) KLS-Martin L.P. | JEY |
| Dec 20, 2007 | K072764 | KLS MARTIN XTERNAL FIXATOR KLS Martin L.P. | MQN |
| Dec 19, 2007 | K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) KLS-Martin L.P. | GXN |
| Mar 26, 2007 | K070169 | KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE KLS Martin L.P. | HRS |
| Nov 22, 2006 | K062857 | KLS MARTIN QUICK DISC KLS Martin L.P. | GXN |
| Oct 31, 2006 | K062570 | PATIENT CONTOURED MESH (PCM) KLS-Martin L.P. | GXN |
| Sep 21, 2006 | K061507 | SONICWELD RX ENDOBROW FIXATION KLS-Martin L.P. | JEY |
Newest 50 of 81.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||