The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc Revision Hip Stem Prosthesis.
Device ID | K873857 |
510k Number | K873857 |
Device Name: | WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Lipscomb, Phd |
Correspondent | Lipscomb, Phd DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-22 |
Decision Date | 1987-12-01 |