510(k) K103582
K103582 is an FDA 510(k) premarket notification submitted by Kelyniam Global, Inc. for the device "KELYNIAM CUSTOM SKULL IMPLANT (CSI)". The FDA issued a decision of Substantially Equivalent on April 14, 2011. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Kelyniam Global, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2011
- Date Received
- December 8, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type