Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K200513 |
Device Name |
DAC Dynamic Active Compression Plate |
Applicant |
Pioneer Surgical Technology, Inc., DBA RTI Surgical |
375 River Park Circle |
Marquette,
MI
49855
|
|
Applicant Contact |
Linda Busklein |
Correspondent |
Pioneer Surgical Technology, Inc., DBA RTI Surgical |
375 River Park Circle |
Marquette,
MI
49855
|
|
Correspondent Contact |
Sarah Pleaugh |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/02/2020 |
Decision Date | 07/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|