510(k) K061599
K061599 is an FDA 510(k) premarket notification submitted by Bk Meditech, Co., Ltd. for the device "PIN SCREW". The FDA issued a decision of Substantially Equivalent on Jul 26, 2006. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Bk Meditech, Co., Ltd. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 26, 2006
- Date Received
- Jun 8, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)