The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ortholoc Advantim Tibial Base Component.
Device ID | K932858 |
510k Number | K932858 |
Device Name: | ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT |
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 | 1993-06-10 |
Decision Date | 1994-02-16 |