Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K181083 |
Device Name |
Stryker All-PEEK Knotless Anchor System |
Applicant |
Stryker |
5900 Optical Ct. |
San Jose,
CA
95138
|
|
Applicant Contact |
Katie Farraro |
Correspondent |
Stryker |
5900 Optical Ct. |
San Jose,
CA
95138
|
|
Correspondent Contact |
Katie Farraro |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 04/24/2018 |
Decision Date | 07/23/2018 |
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
|
|
|