Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K031751 |
Device Name |
RAPIDFIRE SELF DRILLING SCREWS |
Applicant |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Applicant Contact |
KIM REED |
Correspondent |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Correspondent Contact |
KIM REED |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/05/2003 |
Decision Date | 06/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|