The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Custom-hip Tool.
| Device ID | K051181 |
| 510k Number | K051181 |
| Device Name: | CUSTOM-HIP TOOL |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPEDIC SCIENCES, INC 3020 OLD RANCH PARKWAY SUITE 325 Seal Beach, CA 90740 |
| Contact | James K Brannon |
| Correspondent | James K Brannon ORTHOPEDIC SCIENCES, INC 3020 OLD RANCH PARKWAY SUITE 325 Seal Beach, CA 90740 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-09 |
| Decision Date | 2005-05-23 |
| Summary: | summary |