Stryker Pediatric Mandibular Distractor 2
FDA 510(k) K181504 · Stryker
510(k) numberK181504
Submission
- Device name
- Stryker Pediatric Mandibular Distractor 2
- Applicant
- Stryker
Portage, MI, US - Received
- June 7, 2018
- Decision date
- September 11, 2018
- 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 |
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| K162594 | Craniomaxillofacial Distraction System (CMFD)MQN · Traditional | Synthes USA Products, LLC | 05/08/2017SE |
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| K133398 | Stryker Pediatric Mandible DistractorMQN · Traditional | Stryker | 03/20/2014SE |
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| K080542 | DistraxMQN · Traditional | John W. King | 12/15/2008SE |
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Questions and answers
When was Stryker Pediatric Mandibular Distractor 2 cleared by the FDA?
Stryker Pediatric Mandibular Distractor 2 (K181504) received a 510(k) decision of Substantially Equivalent on September 11, 2018, 96 days after the submission was received.
What is the product code of K181504?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.