Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K051309 |
Device Name |
ROI FUSION RODS & PLATES |
Applicant |
REILEY ORTHOPAEDICS, INC. |
1001 OAKWOOD BLVD. |
ROUND ROCK,
TX
78681
|
|
Applicant Contact |
J.D. WEBB |
Correspondent |
REILEY ORTHOPAEDICS, INC. |
1001 OAKWOOD BLVD. |
ROUND ROCK,
TX
78681
|
|
Correspondent Contact |
J.D. WEBB |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 05/19/2005 |
Decision Date | 07/11/2005 |
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
|
|
|