The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Excia Total Hip System.
Device ID | K150062 |
510k Number | K150062 |
Device Name: | Excia Total Hip System |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
Contact | Julie Tom Wing |
Correspondent | Julie Tom Wing AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
Product Code | LZO |
Subsequent Product Code | KWY |
Subsequent Product Code | LWJ |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-13 |
Decision Date | 2015-02-09 |
Summary: | summary |