MBB
- Product code
- MBB
- Device name
- Bone Cement, Antibiotic
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3027
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 19 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252443 | 2025-09-15 | G21, S.R.L. | SpaceFix Shoulder Spacer | |
| K242216 | 2024-12-18 | Teknimed Sas | GENTAFIX® (1, 3, 3MV) | |
| K240856 | 2024-11-20 | Osartis GmbH | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer… |
Official FDA classification page: MBB
Classification and pathway per current FDA publications. Data from openFDA (CC0).