510(k) K123926
K123926 is an FDA 510(k) premarket notification submitted by Metasurg for the device "METASURG NITINOL STAPLE IMPLANT". The FDA issued a decision of Substantially Equivalent on May 3, 2013. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Metasurg has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2013
- Date Received
- December 20, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type