TITAN 3-D Wedge System— 510(k) K162241

Substantially Equivalent

Paragon 28

FDA 510(k) clearance K162241 for TITAN 3-D Wedge System, Substantially Equivalent on 2017-04-03. Applicant: Paragon 28.

Clearance details

Applicant: Paragon 28
Product code: Code PLF
Advisory panel: Orthopedic
Date received: 2016-08-10
Decision date: 2017-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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