Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K153087 |
Device Name |
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved |
Applicant |
Ivy Sports Medicine, LLC |
545 Penobscot Drive |
Redwood City,
CA
94063
|
|
Applicant Contact |
John Dichiara |
Correspondent |
Ivy Sports Medicine, LLC |
545 Penobscot Drive |
Redwood City,
CA
94063
|
|
Correspondent Contact |
John Dichiara |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 10/26/2015 |
Decision Date | 07/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|