510(k) K071471

CORIN ADAPTOR SLEEVE by Howmedica Osteonics Corp. — Product Code KWL

K071471 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "CORIN ADAPTOR SLEEVE". The FDA issued a decision of Substantially Equivalent on September 10, 2007. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2007
Date Received
May 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type