510(k) K080685

HIPLOC COMPRESSION HIP SCREW by Biomet Manufacturing, Inc. — Product Code JDO

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