The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc Ii Unicondylar Knee System.
| Device ID | K881779 |
| 510k Number | K881779 |
| Device Name: | WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Lipscomb, Phd |
| Correspondent | Lipscomb, Phd DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-26 |
| Decision Date | 1988-08-31 |