Mandibular Bone Distractor
FDA 510(k) K945674 · Howmedica Corp.
510(k) numberK945674
Submission
- Device name
- Mandibular Bone Distractor
- Applicant
- Howmedica Corp.
Madrid, ES - Received
- November 18, 1994
- Decision date
- June 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Mandibular Bone Distractor cleared by the FDA?
Mandibular Bone Distractor (K945674) received a 510(k) decision of Substantially Equivalent on June 2, 1995, 196 days after the submission was received.
What is the product code of K945674?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.