510(k) K181504
K181504 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Pediatric Mandibular Distractor 2". The FDA issued a decision of Substantially Equivalent on September 11, 2018. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Stryker has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2018
- Date Received
- June 7, 2018
- 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