The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Metal Transcend Articulation System.
Device ID | K004043 |
510k Number | K004043 |
Device Name: | METAL TRANSCEND ARTICULATION SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Ehab M Esmail |
Correspondent | Ehab M Esmail WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | JDL |
CFR Regulation Number | 888.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-29 |
Decision Date | 2001-07-13 |
Summary: | summary |