Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
|
510(k) Number |
K121890 |
Device Name |
GENESYS PRESSFT SUTURE ANCHOR |
Applicant |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
11311 Concept Boulevard |
LARGO,
FL
33773
|
|
Applicant Contact |
LORNA K LINVILLE |
Correspondent |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
11311 Concept Boulevard |
LARGO,
FL
33773
|
|
Correspondent Contact |
LORNA K LINVILLE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/28/2012 |
Decision Date | 08/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|