The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Dcw Modular Proximal Femoral System.
Device ID | K904028 |
510k Number | K904028 |
Device Name: | DCW MODULAR PROXIMAL FEMORAL SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
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 | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-31 |
Decision Date | 1991-01-14 |