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FDA 510(k)

Stryker Orthopaedics Hip Systems Labeling Update

K-Number: K153345 · 2016-05-25

ApplicantStryker Orthopaedics
Decision Date2016-05-25
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker Orthopaedics Hip Systems Labeling Update is a medical device manufactured by Stryker Orthopaedics. It received FDA 510(k) clearance on 2016-05-25 under approval number K153345. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Orthopaedics Hip Systems Labeling Update?

Stryker Orthopaedics Hip Systems Labeling Update is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Stryker Orthopaedics. The 510(k) number is K153345.

When was Stryker Orthopaedics Hip Systems Labeling Update approved by the FDA?

Stryker Orthopaedics Hip Systems Labeling Update received FDA 510(k) clearance on 2016-05-25, under approval number K153345.

What company makes Stryker Orthopaedics Hip Systems Labeling Update?

Stryker Orthopaedics Hip Systems Labeling Update is manufactured by Stryker Orthopaedics.

What is the FDA product code for Stryker Orthopaedics Hip Systems Labeling Update?

The FDA product code for Stryker Orthopaedics Hip Systems Labeling Update is LPH.

Other Devices by Stryker Orthopaedics

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 K191414EXETER Centralizer, EXETER 2.5mm Plug K211703Insignia Hip Stem

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

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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