Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K110123 |
Device Name |
PCL TIGHTROPE |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/18/2011 |
Decision Date | 04/28/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|