The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Modified Whiteside Posterior Stabilized Total Knee.
Device ID | K862136 |
510k Number | K862136 |
Device Name: | MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE |
Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Spires, Jr |
Correspondent | Spires, Jr DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | HSX |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-04 |
Decision Date | 1986-07-14 |