The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Gladiator Bipolar System.
| Device ID | K062693 |
| 510k Number | K062693 |
| Device Name: | GLADIATOR BIPOLAR SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2006-09-29 |
| Summary: | summary |