The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Hiploc Compression Hip Screw.
| Device ID | K080685 |
| 510k Number | K080685 |
| Device Name: | HIPLOC COMPRESSION HIP SCREW |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Product Code | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-11 |
| Decision Date | 2008-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05019279424580 | K080685 | 000 |
| 05019279410132 | K080685 | 000 |
| 05019279410125 | K080685 | 000 |
| 05019279410118 | K080685 | 000 |
| 05019279410101 | K080685 | 000 |
| 05019279410095 | K080685 | 000 |
| 00887868214844 | K080685 | 000 |