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FDA 510(k)

TITAN 3-D™ Wedge System

K-Number: K162241 · 2017-04-03

ApplicantParagon 28
Decision Date2017-04-03
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITAN 3-D™ Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28. It received FDA 510(k) clearance on 2017-04-03 under 510(k) number K162241. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN 3-D™ Wedge System?

TITAN 3-D™ Wedge System is a medical device that received FDA 510(k) clearance on 2017-04-03. The listed applicant is Paragon 28. The 510(k) number is K162241.

When did TITAN 3-D™ Wedge System receive FDA 510(k) clearance?

TITAN 3-D™ Wedge System received FDA 510(k) clearance on 2017-04-03, under 510(k) number K162241.

Who is the listed applicant for TITAN 3-D™ Wedge System?

The FDA 510(k) record lists Paragon 28 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITAN 3-D™ Wedge System?

The FDA product code for TITAN 3-D™ Wedge System is PLF.

Other records listing Paragon 28 as applicant

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Related Devices (Code: PLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLCK252254Osteotomy Wedge SystemSinaptic SurgicalK251791Auxano® Wedge Fixation SystemAuxano Medical, LLCK240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.K243231Trigon PEEK HA WedgesNvision Biomedical TechnologiesK234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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