Device Classification Name |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
|
510(k) Number |
K071676 |
Device Name |
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS |
Applicant |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
GRAHAM CUTHBERT |
Correspondent |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
GRAHAM CUTHBERT |
Regulation Number | 888.3310
|
Classification Product Code |
|
Date Received | 06/19/2007 |
Decision Date | 07/19/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|