The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Stryker Orthopaedics Hip Systems Labeling Update.
Device ID | K153345 |
510k Number | K153345 |
Device Name: | Stryker Orthopaedics Hip Systems Labeling Update |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Margaret Klippel |
Correspondent | Margaret Klippel STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | LPH |
Subsequent Product Code | HWC |
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 | MAY |
Subsequent Product Code | MBL |
Subsequent Product Code | MEH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-19 |
Decision Date | 2016-05-25 |
Summary: | summary |