The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Dcw Modular Distal Femoral System.
| Device ID | K910596 |
| 510k Number | K910596 |
| Device Name: | DCW MODULAR DISTAL FEMORAL SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Diane D Patton |
| Correspondent | Diane D Patton DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-05-29 |