510(k) K061493
K061493 is an FDA 510(k) premarket notification submitted by Stryker Howmedica Osteonics for the device "APEX PINS". The FDA issued a decision of Substantially Equivalent on July 7, 2006. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2006
- Date Received
- May 31, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type