510(k) K002325
K002325 is an FDA 510(k) premarket notification submitted by Biologically Oriented Prostheses for the device "WUJIN #3 TIBIAL NAIL". The FDA issued a decision of Substantially Equivalent on October 30, 2000. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biologically Oriented Prostheses has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2000
- Date Received
- August 1, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nail, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type