The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Anthology™ Afit Hip Stem.
Device ID | K172684 |
510k Number | K172684 |
Device Name: | Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
Contact | Jonathan Dimotta |
Correspondent | Jonathan Dimotta Smith & Nephew, Inc. 1450 East Brooks Road Memphis, TN 38116 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-06 |
Decision Date | 2017-10-03 |
Summary: | summary |