KLS Martin Xternal Fixator
FDA 510(k) K072764 · KLS Martin L.P.
510(k) numberK072764
Submission
- Device name
- KLS Martin Xternal Fixator
- Applicant
- KLS Martin L.P.
Jacksonville, FL, US - Received
- September 28, 2007
- Decision date
- December 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220050 | KLS Martin IPS DistractionMQN · Traditional | KLS Martin L.P. | 08/11/2022SE |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR ConditionalMQN · Traditional | Synthes (USA) Products, LLC | 03/13/2019SE |
| K181504 | Stryker Pediatric Mandibular Distractor 2MQN · Traditional | Stryker | 09/11/2018SE |
| K162594 | Craniomaxillofacial Distraction System (CMFD)MQN · Traditional | Synthes USA Products, LLC | 05/08/2017SE |
| K161470 | Internal Distraction - SterileMQN · Traditional | KLS Martin L.P. | 12/01/2016SE |
| K143285 | Mandible External Fixator - MR ConditionalMQN · Traditional | Synthes USA Products, LLC | 05/28/2015SE |
| K133398 | Stryker Pediatric Mandible DistractorMQN · Traditional | Stryker | 03/20/2014SE |
| K121502 | Synthes Curvilinear Distraction SystemMQN · Traditional | Synthes, Inc. | 08/23/2012SE |
| K080458 | Mis Crest WidenerMQN · Traditional | Mis - Implant Technologies , Ltd. | 12/17/2008SE |
| K080542 | DistraxMQN · Traditional | John W. King | 12/15/2008SE |
More from John W. King
| 510(k) | Device | Decision |
|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | 08/17/2026SE |
| K254162 | KLS Martin Ixos SystemHRS · Traditional | 02/20/2026SE |
| K253660 | KLS Martin Pure Pectus SystemHRS · Traditional | 02/20/2026SE |
| K250988 | KLS Martin Pure Pectus SystemHRS · Traditional | 12/11/2025SE |
| K250865 | KLS Martin IPS Forearm SystemHRS · Traditional | 11/14/2025SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | 11/10/2025SE |
| K250620 | KLS Martin Ixos SystemHRS · Traditional | 08/15/2025SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | 09/17/2024SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | 08/16/2024SE |
| K241018 | KLS Martin Orthopedic Implants - MR ConditionalHRS · Traditional | 07/12/2024SE |
Questions and answers
When was KLS Martin Xternal Fixator cleared by the FDA?
KLS Martin Xternal Fixator (K072764) received a 510(k) decision of Substantially Equivalent on December 20, 2007, 83 days after the submission was received.
What is the product code of K072764?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.