Synthes External Midface Distractor
FDA 510(k) K040083 · Synthes (Usa)
510(k) numberK040083
Submission
- Device name
- Synthes External Midface Distractor
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- January 15, 2004
- Decision date
- March 31, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Synthes External Midface Distractor cleared by the FDA?
Synthes External Midface Distractor (K040083) received a 510(k) decision of Substantially Equivalent on March 31, 2004, 76 days after the submission was received.
What is the product code of K040083?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.