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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2019-08-28 under 510(k) 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. The listed applicant is Stryker Orthopaedics. The 510(k) number is K191414.

When did EXETER Centralizer, EXETER 2.5mm Plug receive FDA 510(k) clearance?

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

Who is the listed applicant for EXETER Centralizer, EXETER 2.5mm Plug?

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

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.

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Other records listing Stryker Orthopaedics as applicant

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.

K211703Insignia Hip StemK173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsK173849Triathlon Total Knee SystemK172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemK153345Stryker Orthopaedics Hip Systems Labeling Update

Related Devices (Code: JDI)

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.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

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

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