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FDA 510(k)

Escalade Legend Acetabular Shell

K-Number: K161080 · 2016-05-17

ApplicantOrtho Development Corporation
Decision Date2016-05-17
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Escalade Legend Acetabular Shell is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2016-05-17 under approval number K161080. 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 Escalade Legend Acetabular Shell?

Escalade Legend Acetabular Shell is a medical device that received FDA 510(k) clearance on 2016-05-17. It is manufactured by Ortho Development Corporation. The 510(k) number is K161080.

When was Escalade Legend Acetabular Shell approved by the FDA?

Escalade Legend Acetabular Shell received FDA 510(k) clearance on 2016-05-17, under approval number K161080.

What company makes Escalade Legend Acetabular Shell?

Escalade Legend Acetabular Shell is manufactured by Ortho Development Corporation.

What is the FDA product code for Escalade Legend Acetabular Shell?

The FDA product code for Escalade Legend Acetabular Shell is LPH.

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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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