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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 a medical device manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-04-22 under approval 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. It is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K210893.

When was Restoration Anatomic Shell approved by the FDA?

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

What company makes Restoration Anatomic Shell?

Restoration Anatomic Shell is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

What is the FDA product code for Restoration Anatomic Shell?

The FDA product code for Restoration Anatomic Shell is LPH.

Related Clinical Trials

NCT05591859 Restoration Anatomic Acetabular Shell Revision Study WITHDRAWN

Other Devices by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components K171768Trident® II Acetabular System K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts K191358Trident II Acetabular System K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

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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

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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