Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K211582 |
Device Name |
LOQTEQ Proximal Humerus Plate 3.5 System |
Applicant |
aap Implantate AG |
Lorenzweg 5 |
Berlin,
DE
12099
|
|
Applicant Contact |
Agnieszka Mierzejewska |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Melissa Burbage |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/21/2021 |
Decision Date | 10/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|