b-ONE® Total Hip System — B-One Ortho, Corp. (510(k) K173380)
b-ONE® Total Hip System — B-One Ortho, Corp. (510(k) K173380) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: b-ONE® Total Hip System; Applicant: B-One Ortho, Corp.; Clearance track: 510(k).
| Device name | b-ONE® Total Hip System |
|---|---|
| Applicant | B-One Ortho, Corp. |
| Clearance track | 510(k) |
| Submission number | K173380 |
| Decision | Substantially Equivalent |
| Decision date | 2018-08-30 |
| Date received | 2017-10-30 |
| Product code | LZO |
| Device class | 2 |
| Medical specialty | Orthopedic |
| Applicant location | NJ, US |
| Source | openFDA device |
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$1999/mo
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