The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc Modular Tibial Constrain.insert.
| Device ID | K905076 |
| 510k Number | K905076 |
| Device Name: | WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Diane Patton |
| Correspondent | Diane Patton 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 | 1990-11-13 |
| Decision Date | 1991-02-13 |