510(k) K191916
K191916 is an FDA 510(k) premarket notification submitted by Stryker Leibinger GmbH & Co KG for the device "Stryker CMF MEDPOR Priority Customized Implant Kit". The FDA issued a decision of Substantially Equivalent on August 15, 2019. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Stryker Leibinger GmbH & Co KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2019
- Date Received
- July 17, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Chin, Internal
- Device Class
- Class II
- Regulation Number
- 878.3550
- Review Panel
- SU
- Submission Type