Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K092189 |
Device Name |
POGO SCREW |
Applicant |
FXDEVICES |
ONE SOUTH OCEAN BLVD. |
BOCA RATON,
FL
33432
|
|
Applicant Contact |
RICH LIPSCHUTZ |
Correspondent |
FXDEVICES |
ONE SOUTH OCEAN BLVD. |
BOCA RATON,
FL
33432
|
|
Correspondent Contact |
RICH LIPSCHUTZ |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 07/21/2009 |
Decision Date | 09/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|