Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pinnacle Duofix HA Acetabular Cup Prosthesis

K-Number: K192919 · 2019-11-26

ApplicantDePuy Orthopaedics, Inc.
Decision Date2019-11-26
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pinnacle Duofix HA Acetabular Cup Prosthesis is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192919. 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 Pinnacle Duofix HA Acetabular Cup Prosthesis?

Pinnacle Duofix HA Acetabular Cup Prosthesis is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K192919.

When was Pinnacle Duofix HA Acetabular Cup Prosthesis approved by the FDA?

Pinnacle Duofix HA Acetabular Cup Prosthesis received FDA 510(k) clearance on 2019-11-26, under approval number K192919.

What company makes Pinnacle Duofix HA Acetabular Cup Prosthesis?

Pinnacle Duofix HA Acetabular Cup Prosthesis is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis?

The FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis is LPH.

Other Devices by DePuy Orthopaedics, Inc.

K170339Summit Hip System K192946DePuy Corail AMT Hip Prosthesis K182301PFC SIGMA Knee System K203167DePuy Corail AMT Hip Prosthesis K202472ACTIS Duofix Hip Prosthesis K201347DePuy ATTUNE™ Total Knee System

View all 13 devices →

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.

↑