The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Freeman-samuelson Modular Total Knee Replacement.
Device ID | K911972 |
510k Number | K911972 |
Device Name: | FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Webb |
Correspondent | Webb INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-03 |
Decision Date | 1991-10-25 |