The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Ultra Congruent Tibial Insert.
Device ID | K912663 |
510k Number | K912663 |
Device Name: | NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT |
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 | 1991-06-18 |
Decision Date | 1991-09-16 |