510(k) K111008
K111008 is an FDA 510(k) premarket notification submitted by Microware Precision Co., Ltd. for the device "MICROWARE BONE PLATES AND BONE SCREW". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Microware Precision Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2012
- Date Received
- April 11, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type