The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Stageone Select Cement Spacer Molds For Temporary Hip Replacement.
| Device ID | K080979 |
| 510k Number | K080979 |
| Device Name: | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-04-07 |
| Decision Date | 2008-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304521995 | K080979 | 000 |
| 00880304521056 | K080979 | 000 |
| 00880304521063 | K080979 | 000 |
| 00880304521070 | K080979 | 000 |
| 00880304521087 | K080979 | 000 |
| 00880304521094 | K080979 | 000 |
| 00880304521100 | K080979 | 000 |
| 00880304521117 | K080979 | 000 |
| 00880304521124 | K080979 | 000 |
| 00880304521131 | K080979 | 000 |
| 00880304521148 | K080979 | 000 |
| 00880304521155 | K080979 | 000 |
| 00880304521162 | K080979 | 000 |
| 00880304521179 | K080979 | 000 |
| 00880304521230 | K080979 | 000 |
| 00880304521247 | K080979 | 000 |
| 00880304521254 | K080979 | 000 |
| 00880304521032 | K080979 | 000 |