510(k) K153248
K153248 is an FDA 510(k) premarket notification submitted by Stryker for the device "PEEK Customized Cranial Implant". The FDA issued a decision of Substantially Equivalent on March 10, 2016. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Stryker has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2016
- Date Received
- November 9, 2015
- 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