Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K193016 |
Device Name |
PRECICE Bone Transport System |
Applicant |
NuVasive Specialized Orthopedics, Inc. |
101 Enterprise |
Suite 100 |
Aliso Viejo,
CA
92656
|
|
Applicant Contact |
Madison Heffron |
Correspondent |
NuVasive Specialized Orthopedics, Inc. |
101 Enterprise |
Suite 100 |
Aliso Viejo,
CA
92656
|
|
Correspondent Contact |
Madison Heffron |
Regulation Number | 888.3020
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/29/2019 |
Decision Date | 05/08/2020 |
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
|
|
|