The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Regenerex Ultra Porous Construct-femoral And Tibial Knee Augments.
| Device ID | K053505 |
| 510k Number | K053505 |
| Device Name: | REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Tracy B Johnson |
| Correspondent | Tracy B Johnson BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | MBH |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KRO |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-08-14 |
| Summary: | summary |