510(k) K082282
K082282 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Co. for the device "HEALIX TI ANCHOR". The FDA issued a decision of Substantially Equivalent on Nov 7, 2008. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Co. has 61 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 7, 2008
- Date Received
- Aug 11, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)