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FDA 510(k)

EXETER Centralizer, EXETER 2.5mm Plug

K-Number: K191414 · 2019-08-28

ApplicantStryker Orthopaedics
Decision Date2019-08-28
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXETER Centralizer, EXETER 2.5mm Plug is a medical device manufactured by Stryker Orthopaedics. It received FDA 510(k) clearance on 2019-08-28 under approval number K191414. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXETER Centralizer, EXETER 2.5mm Plug?

EXETER Centralizer, EXETER 2.5mm Plug is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Stryker Orthopaedics. The 510(k) number is K191414.

When was EXETER Centralizer, EXETER 2.5mm Plug approved by the FDA?

EXETER Centralizer, EXETER 2.5mm Plug received FDA 510(k) clearance on 2019-08-28, under approval number K191414.

What company makes EXETER Centralizer, EXETER 2.5mm Plug?

EXETER Centralizer, EXETER 2.5mm Plug is manufactured by Stryker Orthopaedics.

What is the FDA product code for EXETER Centralizer, EXETER 2.5mm Plug?

The FDA product code for EXETER Centralizer, EXETER 2.5mm Plug is JDI.

Other Devices by Stryker Orthopaedics

K153345Stryker Orthopaedics Hip Systems Labeling Update K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads K173849Triathlon Total Knee System K211703Insignia Hip Stem

Related Devices (Code: JDI)

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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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