510(k) K110807
K110807 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "ABG II MONOLITHIC HIP STEM". The FDA issued a decision of Substantially Equivalent on May 25, 2011. The device falls under product code MAY (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish), a Class II device regulated under 21 CFR 888.3353. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2011
- Date Received
- March 23, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type