510(k) K110554
K110554 is an FDA 510(k) premarket notification submitted by Ceramisys, Ltd. for the device "BIOCERAMIC ORBITAL IMPLANT, ORBTEX". The FDA issued a decision of Substantially Equivalent on November 2, 2011. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Ceramisys, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2011
- Date Received
- February 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Sphere
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type