The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Dynasty Acetabular System.
Device ID | K070785 |
510k Number | K070785 |
Device Name: | DYNASTY ACETABULAR SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Matt Paul |
Correspondent | Matt Paul WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | JDL |
Subsequent Product Code | JDI |
Subsequent Product Code | KWA |
Subsequent Product Code | LPH |
Subsequent Product Code | MBL |
CFR Regulation Number | 888.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-21 |
Decision Date | 2007-07-11 |