Trident® II Tritanium® Acetabular Shells And 6.5 Mm Low Profile Hex Screws

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® Ii Tritanium® Acetabular Shells And 6.5 Mm Low Profile Hex Screws.

Pre-market Notification Details

• Device ID: K161569
• 510k Number: K161569
• Device Name: Trident® II Tritanium® Acetabular Shells And 6.5 Mm Low Profile Hex Screws
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Howmedica Osteonics Corp. Aka Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430
• Contact: Valerie Giambanco
• Correspondent: Valerie Giambanco; Howmedica Osteonics Corp. Aka Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWZ
• 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: 2016-06-07
• Decision Date: 2016-10-14
• Summary: summary