The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Infinity(tm) Microtaper Hip System.
| Device ID | K913874 |
| 510k Number | K913874 |
| Device Name: | INFINITY(TM) MICROTAPER HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Micki Roy |
| Correspondent | Micki Roy DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1991-11-27 |