The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Dynasty Acetabular System With Ceramic.
| Device ID | K130376 |
| 510k Number | K130376 |
| Device Name: | DYNASTY ACETABULAR SYSTEM WITH CERAMIC |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Dean Nachtrab |
| Correspondent | Dean Nachtrab WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-07-03 |
| Summary: | summary |