510(k) K080685
K080685 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing, Inc. for the device "HIPLOC COMPRESSION HIP SCREW". The FDA issued a decision of Substantially Equivalent on August 15, 2008. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Biomet Manufacturing, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2008
- Date Received
- March 11, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Proximal Femoral, Implant
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type