The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for 23 Mm Single-peg Patella Component.
| Device ID | K061340 |
| 510k Number | K061340 |
| Device Name: | 23 MM SINGLE-PEG PATELLA COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Lester F Padilla |
| Correspondent | Lester F Padilla BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304555754 | K061340 | 000 |
| 00880304555747 | K061340 | 000 |
| 00880304555730 | K061340 | 000 |
| 00880304555723 | K061340 | 000 |
| 00887868344268 | K061340 | 000 |
| 00887868344251 | K061340 | 000 |
| 00887868344244 | K061340 | 000 |
| 00887868344237 | K061340 | 000 |