Synthes (USA) Curvilinear Distraction System
FDA 510(k) K080153 · Synthes (Usa)
510(k) numberK080153
Submission
- Device name
- Synthes (USA) Curvilinear Distraction System
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- January 23, 2008
- Decision date
- May 14, 2008
- 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 |
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Questions and answers
When was Synthes (USA) Curvilinear Distraction System cleared by the FDA?
Synthes (USA) Curvilinear Distraction System (K080153) received a 510(k) decision of Substantially Equivalent on May 14, 2008, 112 days after the submission was received.
What is the product code of K080153?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.