The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ortholoc(r) Advantim(tm) Femoral Component.
| Device ID | K930188 |
| 510k Number | K930188 |
| Device Name: | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT |
| 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 | 1993-01-14 |
| Decision Date | 1993-08-03 |