Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K083240 |
Device Name |
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES |
Applicant |
ARTHROCARE CORP. |
15285 ALTON PARKWAY |
SUITE 200 |
IRVINE,
CA
92618
|
|
Applicant Contact |
LAURA N KASPEROWICZ |
Correspondent |
ARTHROCARE CORP. |
15285 ALTON PARKWAY |
SUITE 200 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
LAURA N KASPEROWICZ |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 11/03/2008 |
Decision Date | 01/12/2009 |
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
|
|
|