510(k) K182711
K182711 is an FDA 510(k) premarket notification submitted by Kelyniam Global, Inc. for the device "Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)". The FDA issued a decision of Substantially Equivalent on May 21, 2019. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Kelyniam Global, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2019
- Date Received
- September 27, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Alterable
- Device Class
- Class II
- Regulation Number
- 882.5320
- Review Panel
- NE
- Submission Type