The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Metal Screw Anchor.
| Device ID | K012503 |
| 510k Number | K012503 |
| Device Name: | METAL SCREW ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-03 |
| Decision Date | 2001-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304453418 | K012503 | 000 |
| 00880304008434 | K012503 | 000 |
| 00880304009677 | K012503 | 000 |
| 00880304404311 | K012503 | 000 |
| 00880304404328 | K012503 | 000 |
| 00880304404335 | K012503 | 000 |
| 00880304404359 | K012503 | 000 |
| 00880304404373 | K012503 | 000 |
| 00880304404380 | K012503 | 000 |
| 00880304404403 | K012503 | 000 |
| 00880304432093 | K012503 | 000 |
| 00880304432109 | K012503 | 000 |
| 00880304008298 | K012503 | 000 |