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510(k) K201315

Device
PERFORM Humeral System – Stem
Applicant
Tornier, Inc.
510(k) number
K201315
Product code
PAO  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-11
Date received
2020-05-18
Regulation
888.3660
Classification name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Renee Stoffel
Address
10801 Nesbitt Ave. S. Bloomington MN US 55437 55437

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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