The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Conserve Total Femoral Head.
Device ID | K051348 |
510k Number | K051348 |
Device Name: | CONSERVE TOTAL FEMORAL HEAD |
Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
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 | JDL |
CFR Regulation Number | 888.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-24 |
Decision Date | 2005-08-19 |
Summary: | summary |