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FDA 510(k)

Restoration Anatomic Shell

K-Number: K210893 · 2021-04-22

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2021-04-22
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Restoration Anatomic Shell is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K210893. 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 Restoration Anatomic Shell?

Restoration Anatomic Shell is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K210893.

When did Restoration Anatomic Shell receive FDA 510(k) clearance?

Restoration Anatomic Shell received FDA 510(k) clearance on 2021-04-22, under 510(k) number K210893.

Who is the listed applicant for Restoration Anatomic Shell?

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

What is the FDA product code for Restoration Anatomic Shell?

The FDA product code for Restoration Anatomic Shell is LPH.

Related Clinical Trials

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.

NCT05591859Restoration Anatomic Acetabular Shell Revision StudyWITHDRAWN

Other records listing Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as applicant

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Related Devices (Code: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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