The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Patellofemoral Joint Prosthesis.
Device ID | K962190 |
510k Number | K962190 |
Device Name: | PATELLOFEMORAL JOINT PROSTHESIS |
Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Sam Mirza |
Correspondent | Sam Mirza INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | KRR |
CFR Regulation Number | 888.3540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-06 |
Decision Date | 1996-10-28 |
Summary: | summary |