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.
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 |