Data / Medical devices / United States / KLS-Martin L.P.
KLS-Martin L.P.: FDA-registered device maker in Jacksonville, FL, United States, 64 510(k) clearances
KLS-Martin L.P. is registered with the FDA (registration 1057946) in Jacksonville, FL, United States. It lists 157 device types. The FDA files 64 510(k) clearances under its listings, the newest dated February 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1057946
- FEI number
- 1000525271
- Address
- 11201 Saint Johns Industrial Pkwy S, Jacksonville, FL, United States, 32246
- Owner or operator
- KLS Martin SE & Co. KG (10089006)
- Roles
- Specification developer
- First device listed
- October 27, 2023
- Registered through
- 2027
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2026 | K254162 | KLS Martin Ixos System | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| February 20, 2026 | K253660 | KLS Martin Pure Pectus System | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| December 11, 2025 | K250988 | KLS Martin Pure Pectus System | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| November 14, 2025 | K250865 | KLS Martin IPS Forearm System | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| November 10, 2025 | 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 | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| August 15, 2025 | K250620 | KLS Martin Ixos System | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| September 17, 2024 | K233721 | KLS Martin Drill-Free MMF Screw | DZL | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| July 12, 2024 | K241018 | KLS Martin Orthopedic Implants - MR Conditional | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| November 21, 2023 | K230211 | CranioXpand | PBJ | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| May 25, 2023 | K222624 | KLS Martin LINOS Wrist System | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| March 29, 2023 | K222397 | KLS Martin Level One Rib Fixation System | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| March 28, 2023 | K221938 | KLS Martin Pure Pectus System | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| August 11, 2022 | K220050 | KLS Martin IPS Distraction | MQN | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| July 18, 2022 | K210731 | KLS Martin Individual Patient Solutions | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| July 8, 2022 | K210228 | KLS Martin IPS Preprosthetic | ELE | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| June 3, 2022 | K210741 | KLS Martin Neuro Rongeurs | HAE | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| August 31, 2020 | K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | PPT | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| March 11, 2020 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | PBF | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| November 22, 2019 | K191028 | KLS Martin Individual Patient Solutions | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| July 26, 2019 | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | PPT | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| March 11, 2019 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | DZJ | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| September 13, 2018 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | DZJ | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| August 13, 2018 | K180962 | KLS Martin Individual Patient Solutions | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| February 23, 2018 | K173320 | KLS Martin L1 MMF System | JEY | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| November 21, 2017 | K163579 | KLS Martin Individual Patient Solutions | JEY | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| May 5, 2017 | K163315 | Internal Distraction - Sterile | PBJ | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| March 9, 2017 | K170124 | Level One Hand Plating System | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| December 19, 2016 | K161259 | KLS Martin Cannulated Headless Screws | HWC | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| December 1, 2016 | K161470 | Internal Distraction - Sterile | MQN | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| April 6, 2016 | K153482 | KLS Martin Thoracic Plating System | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| April 6, 2016 | K151983 | KLS Martin LSS Plating System | JDQ | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| November 9, 2015 | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | GXN | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| July 24, 2014 | K141489 | LINOS MOH HAND PLATING SYSTEM | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| May 15, 2014 | K133304 | RXG DISTRACTION SYSTEM | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| January 17, 2013 | K121606 | RESORB-X G | GWO | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| November 14, 2012 | K122860 | KLS MARTIN RECON TALON | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| March 23, 2012 | K112064 | RESORB X-G | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| March 31, 2009 | K083432 | DRILL FREE MMF SCREW | DZL | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| July 21, 2008 | K080862 | SONICWELD RX (RESORB-X) | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| December 20, 2007 | K072764 | KLS MARTIN XTERNAL FIXATOR | MQN | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| December 19, 2007 | K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | GXN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| March 26, 2007 | K070169 | KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE | HRS | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| October 31, 2006 | K062570 | PATIENT CONTOURED MESH (PCM) | GXN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| April 18, 2006 | K060177 | KLS MARTIN RIGID FIXATION - STERILE | JEY | Substantially Equivalent | KLS Martin L.P. | accessdata.fda.gov |
| October 18, 2004 | K042573 | KLS MARTIN DRILL-FREE MMF SCREW | DZL | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| August 25, 2004 | K042066 | KLSA MARTIN HAND DISTRACTOR | JEC | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| May 28, 2004 | K040891 | KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) | DZE | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| May 13, 2004 | K040598 | KLS MARTIN HAND PLATING SYSTEM | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| February 27, 2004 | K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | MQN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| January 15, 2004 | K033483 | KLS-MARTIN ORTHO ANCHORAGE SYSTEM | DZE | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| October 29, 2003 | K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | MQN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| October 10, 2003 | K032413 | KLS-MARTIN STERNAL PLATING SYSTEM | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| July 27, 2001 | K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | NEI | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| June 29, 2001 | K010139 | ZURICH DISTRACTION SYSTEM | MQN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| October 10, 2000 | K002152 | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION | MQN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| February 15, 2000 | K994154 | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| December 21, 1999 | K980760 | KLS-MARTIN MMF SCREW | DZL | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| January 26, 1999 | K983809 | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR | MQN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| June 24, 1997 | K972047 | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE | MQN | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| May 8, 1997 | K971297 | CENTRE-DRIVE DRILL-FREE SCREW | HRS | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| October 18, 1994 | K944565 | KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| October 18, 1994 | K944561 | MICRO OSTEOSYNTHESIS SYSTEM (1.0) | JEY | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| October 4, 1994 | K943348 | KLS CHIN PLATE SYSTEM | JEY | Substantially Equivalent | Patton, Boggs & Blow | accessdata.fda.gov |
| October 4, 1994 | K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM | JEY | Substantially Equivalent | Patton, Boggs & Blow | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Ear Suction
- All makers of Battery, Replacement, Rechargeable
- All makers of Curette, Uterine
- All makers of Cranial Surgical Planning And Instrument Guides
- All makers of Pliers, Operative
- All makers of Guide, Surgical, Instrument
Updated February 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.