The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Whiteside Ortholoc Ii Unicondylar Knee System.
Device ID | K881779 |
510k Number | K881779 |
Device Name: | WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM |
Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
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 | HSX |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-26 |
Decision Date | 1988-08-31 |