Device Classification Name |
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
|
510(k) Number |
K043310 |
Device Name |
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Applicant Contact |
LISA M BOYLE |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Correspondent Contact |
LISA M BOYLE |
Regulation Number | 878.4820
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/01/2004 |
Decision Date | 01/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|