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. Device class: 2.

Clearance details

Applicant: Paragon 28
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2016-08-10
Decision date: 2017-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K162241

K-number listed on FDA's recall record

Z-0662-2020 — P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use OnlyClass II·Terminated·Paragon 28, Inc.·20180928

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162241.

Data sourced from openFDA. This site is unofficial and independent of the FDA.