The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Infinity(tm) Porous-coated Trochanteric Module.
| Device ID | K911595 |
| 510k Number | K911595 |
| Device Name: | INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| 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 | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-07-12 |