The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc Ii Metal Backed Patella.
| Device ID | K864627 |
| 510k Number | K864627 |
| Device Name: | WHITESIDE ORTHOLOC II METAL BACKED PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Bailey Lipscomb |
| Correspondent | Bailey Lipscomb DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-25 |
| Decision Date | 1987-02-04 |