Device Classification Name |
instrument, biopsy
|
510(k) Number |
K210631 |
Device Name |
Avitus(r) Bone Harvester |
Applicant |
Avitus Orthopaedics, Inc. |
6 Amstrong Rd, Suite 107 |
Shelton,
CT
06484
|
|
Applicant Contact |
Maxim Budyansky |
Correspondent |
Keystone Regulatory Services, LLC |
342 E. Main Street |
Leola,
PA
17540
|
|
Correspondent Contact |
William McLain |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 03/03/2021 |
Decision Date | 03/31/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|