510(k) K143285
K143285 is an FDA 510(k) premarket notification submitted by Synthes USA Products, LLC for the device "Mandible External Fixator - MR Conditional". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Synthes USA Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2015
- Date Received
- November 17, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Mandibular Fixator And/Or Distractor
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type