Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
More FDA Info for this Device |
510(K) Number |
K010081 |
Device Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Applicant |
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
Other 510(k) Applications for this Company
|
Contact |
Lisa Simpson
Other 510(k) Applications for this Contact |
Regulation Number |
888.3390
More FDA Info for this Regulation Number |
Classification Product Code |
KWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/10/2001 |
Decision Date |
02/05/2001 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|