Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
|
510(k) Number |
K203495 |
Device Name |
Arthrex SwiveLock Anchor |
Applicant |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108
|
|
Applicant Contact |
Kelsey Roberts |
Correspondent |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108
|
|
Correspondent Contact |
Kelsey Roberts |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/27/2020 |
Decision Date | 04/19/2021 |
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
|
|
|