Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K200259 |
Device Name |
Headless Compression Screw System |
Applicant |
OsteoCentric Extremities, LLC |
5113 Southwest Parkway, Suite 150 |
Austin,
TX
78735
|
|
Applicant Contact |
Todd Evans |
Correspondent |
Empirical Testing Corp. |
4628 Northpark Drive |
Colorado Springs,
CO
80918
|
|
Correspondent Contact |
Meredith May |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/03/2020 |
Decision Date | 05/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|