The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Porous-coated Titanium Acetabular Cup.
Device ID | K894965 |
510k Number | K894965 |
Device Name: | POROUS-COATED TITANIUM ACETABULAR CUP |
Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
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 | JDL |
CFR Regulation Number | 888.3320 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-07 |
Decision Date | 1989-11-17 |