Synthes Curvilinear Distraction System
FDA 510(k) K121502 · Synthes, Inc.
510(k) numberK121502
Submission
- Device name
- Synthes Curvilinear Distraction System
- Applicant
- Synthes, Inc.
West Chester, PA, US - Received
- May 21, 2012
- Decision date
- August 23, 2012
- 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 |
| K080458 | Mis Crest WidenerMQN · Traditional | Mis - Implant Technologies , Ltd. | 12/17/2008SE |
| K080542 | DistraxMQN · Traditional | John W. King | 12/15/2008SE |
| K080153 | Synthes (USA) Curvilinear Distraction SystemMQN · Traditional | Synthes (Usa) | 05/14/2008SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating SystemHRS · Traditional | 03/10/2026SE |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating SystemHRS · Traditional | 03/09/2026SE |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | 11/12/2025SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | 04/11/2013SE |
Questions and answers
When was Synthes Curvilinear Distraction System cleared by the FDA?
Synthes Curvilinear Distraction System (K121502) received a 510(k) decision of Substantially Equivalent on August 23, 2012, 94 days after the submission was received.
What is the product code of K121502?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.