Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K963206 |
Device Name |
S-ROM HIP SYSTEM - LOCKING PLUG |
Applicant |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
JENNIFER L MORSE |
Correspondent |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
JENNIFER L MORSE |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 08/16/1996 |
Decision Date | 10/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|