The following data is part of a premarket notification filed by Howmedica Osteonics Corp., Dba Stryker Orthopaedics with the FDA for Avon Patello-femoral Joint Prosthesis.
Device ID | K211303 |
510k Number | K211303 |
Device Name: | Avon Patello-femoral Joint Prosthesis |
Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430 |
Contact | Shraddha More |
Correspondent | Shraddha More Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430 |
Product Code | KRR |
CFR Regulation Number | 888.3540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-29 |
Decision Date | 2021-06-04 |