The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Perfecta Rs Lateralized Hip Stem, Bridge Hip System.
| Device ID | K991123 |
| 510k Number | K991123 |
| Device Name: | PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Lynne Witkowski |
| Correspondent | Lynne Witkowski WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-02 |
| Decision Date | 1999-06-01 |
| Summary: | summary |