The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Conserve Pressfit Femoral Component.
Device ID | K082673 |
510k Number | K082673 |
Device Name: | CONSERVE PRESSFIT FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Femoral, Resurfacing |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Theresa Leister |
Correspondent | Theresa Leister WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | KXA |
CFR Regulation Number | 888.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-15 |
Decision Date | 2008-12-12 |
Summary: | summary |