The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Condylar Ii Total Knee Prosthesis.
| Device ID | K861715 |
| 510k Number | K861715 |
| Device Name: | WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Walter Spires |
| Correspondent | Walter Spires DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-05 |
| Decision Date | 1986-07-14 |