Device Classification Name |
Pin, Fixation, Threaded
|
510(k) Number |
K955848 |
Device Name |
ORTHOFIX MODULSYSTEM |
Applicant |
ORTHOFIX, INC. |
12300 TWINBROOK PKWY. |
SUITE 625 |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
ROBERT L SHERIDAN |
Correspondent |
ORTHOFIX, INC. |
12300 TWINBROOK PKWY. |
SUITE 625 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
ROBERT L SHERIDAN |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 12/27/1995 |
Decision Date | 03/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|