Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K090835 |
Device Name |
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
JOY LOVETT |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
JOY LOVETT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 03/27/2009 |
Decision Date | 06/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|