Medical Device Manufacturer · US , Jacksonville , FL

KLS-Martin L.P.

78 submissions · 78 cleared · Since 1994
78
Total
78
Cleared
0
Denied

KLS-Martin L.P. — FDA 510(k) Submissions

KLS-Martin L.P. has submitted 78 FDA 510(k) premarket notifications since 1994, of which 78 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Bone, Plate, Fixation, Bone, External Mandibular Fixator And/or Distractor, Plate, Cranioplasty, Preformed, Non-alterable, Screw, Fixation, Intraosseous . Use the specialty filter in the sidebar to narrow results.

78 devices
1–25 of 78
KLS Martin Pure Pectus System
K253660 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2026 92d
KLS Martin Ixos System
K254162 · Orthopedic
Feb 2026 60d
KLS Martin Pure Pectus System
K250988 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2025 255d
KLS Martin IPS Forearm System
K250865 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2025 238d
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
K252573 · GXN Plate, Cranioplasty,... · Neurology
Nov 2025 88d
KLS Martin Ixos System
K250620 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2025 168d
KLS Martin Drill-Free MMF Screw
K233721 · DZL Screw, Fixation,... · Dental
Sep 2024 301d
KLS Martin Oral-Max Implants MR Conditional (bundled)
K241314 · JEY Plate, Bone · Dental
Aug 2024 98d
KLS Martin Orthopedic Implants - MR Conditional
K241018 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2024 88d
CranioXpand
K230211 · PBJ Cranial Distraction System · Neurology
Nov 2023 299d
KLS Martin LINOS Wrist System
K222624 · HRS Plate, Fixation, Bone · Orthopedic
May 2023 267d
KLS Martin Level One Rib Fixation System
K222397 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2023 233d
KLS Martin Pure Pectus System
K221938 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2023 270d
KLS Martin IPS Distraction
K220050 · MQN External Mandibular... · Dental
Aug 2022 217d
KLS Martin Individual Patient Solutions
K210731 · JEY Plate, Bone · Dental
Jul 2022 494d
KLS Martin IPS Preprosthetic
K210228 · ELE Implant, Subperiosteal · Dental
Jul 2022 526d
KLS Martin Neuro Rongeurs
K210741 · HAE Rongeur, Manual · Neurology
Jun 2022 448d
KLS Martin Individual Patient Solutions (IPS) Planning System
K201052 · PPT Cranial Surgical Planning... · Neurology
Aug 2020 132d
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · PBF Orthopaedic Surgical... · Orthopedic
Mar 2020 139d
KLS Martin Individual Patient Solutions
K191028 · JEY Plate, Bone · Dental
Nov 2019 218d
KLS Martin Individual Patient Solutions (IPS) Planning System
K182889 · PPT Cranial Surgical Planning... · Neurology
Jul 2019 284d
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789 · DZJ Driver, Wire, And Bone... · Dental
Mar 2019 161d
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · DZJ Driver, Wire, And Bone... · Dental
Sep 2018 126d
KLS Martin Individual Patient Solutions
K180962 · JEY Plate, Bone · Dental
Aug 2018 123d
KLS Martin L1 MMF System
K173320 · JEY Plate, Bone · Dental
Feb 2018 126d

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