Trident X3 Acetabular Inserts, ADM And MDM X3 Acetabular Inserts, Accolade II Hip System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Howmedica Osteonics Corp Aka Stryker Orthopaedics

The following data is part of a premarket notification filed by Howmedica Osteonics Corp Aka Stryker Orthopaedics with the FDA for Trident X3 Acetabular Inserts, Adm And Mdm X3 Acetabular Inserts, Accolade Ii Hip System.

Pre-market Notification Details

• Device ID: K182468
• 510k Number: K182468
• Device Name: Trident X3 Acetabular Inserts, ADM And MDM X3 Acetabular Inserts, Accolade II Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430
• Contact: Shahrir Alam
• Correspondent: Krutanjali Shah; Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-10
• Decision Date: 2019-03-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327338799	K182468	000
07613327339697	K182468	000
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