510(k) K160071
- Device
- StageOne Disposable Cement Spacer Molds For Temporary Hemi-Shoulder Prosthesis
- Applicant
- Biomet, Inc.
- 510(k) number
- K160071
- Product code
- MBB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-16
- Date received
- 2016-01-13
- Regulation
- 888.3027
- Classification name
- Bone Cement, Antibiotic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carmen Albany
- Address
- 56 E Bell Dr. Warsaw IN US 46581 46581
FDA Registration Numbers#
- 1721676
- 9615014
- 3009732568
- 3015219237
- 9616671
- 1818910
- 1450662
- 1825034
- 3002807314
- 9610921
- 3008110533
- 9681465
- 3010097171
- 3013176080
- 3002907620
- 1836357
- 3002808022
- 3015207155
- 3007663067
- 3008132398
- 3035366890
- 9610726
- 3013055499
- 3010537287
- 1424263
- 2249697
- 3014252644
- 3008812251
- 2025182
- 3005180920
- 3013186738
- 3005941719
- 3014315560
- 1526534
- 3006524618
- 3021566676
- 1644408
- 9614841
- 1722511
- 3006406161
- 3008744062
- 9615788
- 3006946279
- 3004638532
- 3010898856
Source Documents#
Other 510(k) Records For Product Code MBB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025-09-15 |
| K242216 | GENTAFIX® (1, 3, 3MV) | Teknimed Sas | 2024-12-18 |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024-11-20 |
| K222760 | StageOne™ Select Hip Cement Spacer Molds | Biomet, Inc. | 2022-12-28 |
| K221968 | StageOne™ Shoulder Cement Spacer Molds | Biomet, Inc. | 2022-09-15 |
| K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | 2022-09-02 |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021-02-17 |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020-08-13 |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019-10-29 |
| K190216 | SpaceFlex Knee | G21, S.R.L. | 2019-06-09 |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | Biomet, Inc. | 2017-01-25 |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Biomet, Inc. | 2016-09-08 |
| K150850 | Refobacin Bone Cement R | Biomet, Inc. | 2015-07-16 |
| K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS | Biomet Manufacturing Corp | 2014-01-22 |
| K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2008-05-14 |
Legacy Summary#
summary
FDA Review#
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