Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K140674 |
Device Name |
EXACTECH TAPERED WEDGE FEMORAL STEM |
Applicant |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
SHING JEN TAI, PHD |
Correspondent |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
SHING JEN TAI, PHD |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/18/2014 |
Decision Date | 06/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|