Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K000788 |
Device Name |
APEX MODULAR HIP STEM |
Applicant |
APEX SURGICAL, LLC. |
39 TAUNTON GREEN, SUITE 202 |
TAUNTON,
MA
02780
|
|
Applicant Contact |
EDWARD J CHEAL |
Correspondent |
APEX SURGICAL, LLC. |
39 TAUNTON GREEN, SUITE 202 |
TAUNTON,
MA
02780
|
|
Correspondent Contact |
EDWARD J CHEAL |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 03/10/2000 |
Decision Date | 08/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|