The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Evolution Hip System.
Device ID | K896105 |
510k Number | K896105 |
Device Name: | EVOLUTION HIP SYSTEM |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Micki Roy |
Correspondent | Micki Roy DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-20 |
Decision Date | 1989-12-29 |