510(k) K063726
K063726 is an FDA 510(k) premarket notification submitted by Smith & Nephew Inc., Endoscopy Div. for the device "PLC SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on March 6, 2007. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew Inc., Endoscopy Div. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2007
- Date Received
- December 15, 2006
- Clearance Type
- Traditional
- 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