The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Disposable Cement Spacer Molds For Temporary Knee Prostheses.
| Device ID | K050210 |
| 510k Number | K050210 |
| Device Name: | DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 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 | 2005-01-28 |
| Decision Date | 2005-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304007031 | K050210 | 000 |
| 00887868543241 | K050210 | 000 |
| 00887868543258 | K050210 | 000 |
| 00887868543265 | K050210 | 000 |
| 00887868543272 | K050210 | 000 |
| 00887868543289 | K050210 | 000 |
| 00887868543296 | K050210 | 000 |
| 00887868543302 | K050210 | 000 |
| 00880304001176 | K050210 | 000 |
| 00880304001183 | K050210 | 000 |
| 00880304001824 | K050210 | 000 |
| 00880304001831 | K050210 | 000 |
| 00880304002630 | K050210 | 000 |
| 00880304002647 | K050210 | 000 |
| 00880304002661 | K050210 | 000 |
| 00887868543234 | K050210 | 000 |