SMARTSET GMV GENTAMICIN BONE CEMENT
FDA 510(k) clearance K081163 · decided 2008-05-14
Clearance details
- K-number
- K081163
- Device name
- SMARTSET GMV GENTAMICIN BONE CEMENT
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-24
- Decision date
- 2008-05-14
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- MBB
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| GENTAFIX® (1, 3, 3MV) (K242216) | Teknimed Sas | 2024-12-18 |
| Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (K240856) | Osartis GmbH | 2024-11-20 |
| StageOne™ Select Hip Cement Spacer Molds (K222760) | Biomet, Inc. | 2022-12-28 |
| StageOne™ Shoulder Cement Spacer Molds (K221968) | Biomet, Inc. | 2022-09-15 |
| StageOne Knee Cement Spacer Molds (K213287) | Biomet, Inc. | 2022-09-02 |
| SpaceFlex Shoulder (K202338) | G21, S.R.L. | 2021-02-17 |
| SpaceFlex Knee - 80mm Size (K201960) | G21, S.R.L. | 2020-08-13 |
| G21 SpaceFlex Hip (K192041) | G21, S.R.L. | 2019-10-29 |
| SpaceFlex Knee (K190216) | G21, S.R.L. | 2019-06-09 |
| StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273) | Biomet, Inc. | 2017-01-25 |
| StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166) | Biomet, Inc. | 2016-09-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |