The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Lacey Press-fit Condylar Total Knee.
Device ID | K864518 |
510k Number | K864518 |
Device Name: | LACEY PRESS-FIT CONDYLAR TOTAL KNEE |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-17 |
Decision Date | 1987-03-04 |