The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc (tm).
| Device ID | K864070 |
| 510k Number | K864070 |
| Device Name: | WHITESIDE ORTHOLOC (TM) |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Spires Jr. |
| Correspondent | Spires Jr. DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1987-01-27 |