The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Ts-bone Hip Tool.
| Device ID | K063709 |
| 510k Number | K063709 |
| Device Name: | TS-BONE 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 | 2006-12-14 |
| Decision Date | 2007-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813892020083 | K063709 | 000 |
| 00813892020076 | K063709 | 000 |
| 00813892020069 | K063709 | 000 |
| 00813892020052 | K063709 | 000 |
| 00813892020045 | K063709 | 000 |
| 00813892020038 | K063709 | 000 |
| 00813892020021 | K063709 | 000 |
| 00813892020014 | K063709 | 000 |
| 00813892020007 | K063709 | 000 |