The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc M.a. Tibial Base.
| Device ID | K894504 |
| 510k Number | K894504 |
| Device Name: | WHITESIDE ORTHOLOC M.A. TIBIAL BASE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Diane Deere |
| Correspondent | Diane Deere DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-10-17 |