510(k) K073281
K073281 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "CAIS STAPLE". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2008
- Date Received
- Nov 21, 2007
- 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
- 510(k)