The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Stage One Disposable Cement Spacer Molds For Temporary Hemi-shoulder Prosthesis.
| Device ID | K131135 |
| 510k Number | K131135 |
| Device Name: | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS |
| Classification | Bone Cement, Antibiotic |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Carmen Albany |
| Correspondent | Carmen Albany BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBB |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-04-22 |
| Decision Date | 2014-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304551114 | K131135 | 000 |
| 00887868543197 | K131135 | 000 |
| 00887868543203 | K131135 | 000 |
| 00887868543210 | K131135 | 000 |
| 00887868543227 | K131135 | 000 |
| 00880304551008 | K131135 | 000 |
| 00880304551015 | K131135 | 000 |
| 00880304551091 | K131135 | 000 |
| 00880304551107 | K131135 | 000 |
| 00887868543180 | K131135 | 000 |