The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Excia Total Hip System 36mm Ceramic Head.
Device ID | K062684 |
510k Number | K062684 |
Device Name: | EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Kathy A Racosky |
Correspondent | Kathy A Racosky AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | LZO |
Subsequent Product Code | JDI |
Subsequent Product Code | LWJ |
Subsequent Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-08 |
Decision Date | 2006-11-22 |
Summary: | summary |