Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K101448 |
Device Name |
OPUS SPEEDSCREW SYSTEM |
Applicant |
ARTHROCARE CORP. |
680 VAQUEROS AVE. |
SUNNYVALE,
CA
94085 -3523
|
|
Applicant Contact |
LAURA N KASPEROWICZ |
Correspondent |
ARTHROCARE CORP. |
680 VAQUEROS AVE. |
SUNNYVALE,
CA
94085 -3523
|
|
Correspondent Contact |
LAURA N KASPEROWICZ |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 05/24/2010 |
Decision Date | 06/21/2010 |
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
|
|
|