Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K201315
Device Classification Name
More FDA Info for this Device
510(K) Number
K201315
Device Name
PERFORM Humeral System û Stem
Applicant
Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington, MN 55437 US
Other 510(k) Applications for this Company
Contact
Renee Stoffel
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PAO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2020
Decision Date
09/11/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact