510(k) K110926
K110926 is an FDA 510(k) premarket notification submitted by Biomaterials Korea, Inc. for the device "BONE PLATE; BONE SCREW". The FDA issued a decision of Substantially Equivalent on December 8, 2011. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Biomaterials Korea, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2011
- Date Received
- April 1, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type