FDA Product Code
FDA Product Code MBB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3027
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025-09-15 | Traditional | PDF ↗ |
| K242216 | GENTAFIX® (1, 3, 3MV) | Teknimed Sas | 2024-12-18 | Traditional | PDF ↗ |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024-11-20 | Traditional | PDF ↗ |
| K222760 | StageOne Select Hip Cement Spacer Molds | Biomet, Inc. | 2022-12-28 | Traditional | PDF ↗ |
| K221968 | StageOne Shoulder Cement Spacer Molds | Biomet, Inc. | 2022-09-15 | Traditional | PDF ↗ |
| K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | 2022-09-02 | Traditional | PDF ↗ |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021-02-17 | Traditional | PDF ↗ |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020-08-13 | Special | PDF ↗ |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019-10-29 | Traditional | PDF ↗ |
| K190216 | SpaceFlex Knee | G21, S.R.L. | 2019-06-09 | Traditional | PDF ↗ |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | Biomet, Inc. | 2017-01-25 | Traditional | PDF ↗ |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Biomet, Inc. | 2016-09-08 | Traditional | PDF ↗ |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016-06-16 | Traditional | PDF ↗ |
| K150850 | Refobacin Bone Cement R | Biomet, Inc. | 2015-07-16 | Traditional | PDF ↗ |
| K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS | Biomet Manufacturing Corp | 2014-01-22 | Traditional | PDF ↗ |
| K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2008-05-14 | Special | PDF ↗ |
| K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | Howmedica Osteonics Corp. | 2007-02-26 | Traditional | PDF ↗ |
| K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2006-06-08 | Traditional | PDF ↗ |
| K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2005-11-22 | Special | PDF ↗ |
Product code MBB · Class II · Orthopedic. Data: openFDA.