The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Femoral Cement Restrictor.
| Device ID | K800144 |
| 510k Number | K800144 |
| Device Name: | FEMORAL CEMENT RESTRICTOR |
| Classification | Nail, Fixation, Bone |
| Applicant | BIOMET, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-21 |
| Decision Date | 1980-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304255142 | K800144 | 000 |
| 00880304002623 | K800144 | 000 |
| 00880304004078 | K800144 | 000 |
| 00880304004085 | K800144 | 000 |
| 00880304004092 | K800144 | 000 |
| 00880304004108 | K800144 | 000 |
| 00880304005624 | K800144 | 000 |
| 00880304005631 | K800144 | 000 |
| 00880304227354 | K800144 | 000 |
| 00880304227361 | K800144 | 000 |
| 00887868259838 | K800144 | 000 |