The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ortholoc Advantim Tibial Stem 5 Degree.
| Device ID | K930228 |
| 510k Number | K930228 |
| Device Name: | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Diann Atchison |
| Correspondent | Diann Atchison 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 | 1993-01-19 |
| Decision Date | 1993-11-30 |