CONFIDENCE Spinal Cement System
FDA 510(k) clearance K201831 · decided 2020-08-31
Clearance details
- K-number
- K201831
- Device name
- CONFIDENCE Spinal Cement System
- Applicant
- Depuy Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-02
- Decision date
- 2020-08-31
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XeliteMed SuperM-Fix Spinal Bone Cement (K251896) | Xelite Biomed , Ltd. | 2026-01-28 |
| VCFix Spinal System (K250637) | Amber Implants | 2025-05-30 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (K243537) | Xelite Biomed , Ltd. | 2025-04-11 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775) | Xelite Biomed , Ltd. | 2024-09-18 |
| Balloon Inflation System (K232842) | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 |
| V-STRUT® Vertebral Implant (K240084) | Hyprevention | 2024-02-09 |
| Renova Spine Balloon Catheter (K231340) | Biopsybell S.R.L. | 2023-10-30 |
| INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697) | Slk Ortho, LLC | 2023-03-03 |
| SpineJack® Expansion Kit (K223294) | Stryker Instruments | 2022-12-20 |
| KYPHON VuE Bone Cement (K220131) | Tecres S.P.A. | 2022-04-18 |
| TRACKER Plus Kyphoplasty System (K211797) | GS Medical Co., Ltd. | 2021-10-28 |
| SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (K211238) | Stryker Instruments | 2021-06-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005) | Depuy Spine, Inc. | 2011-02-08 |
| IN MOTION ARTIFICIAL DISC (P040006/S004) | Depuy Spine, Inc. | 2007-09-05 |
| CHARITE ARTIFICIAL DISC (P040006/S003) | Depuy Spine, Inc. | 2006-12-15 |
| CHARITE ARTIFICIAL DISC (P040006/S002) | Depuy Spine, Inc. | 2006-03-29 |
| CHARITE ARTIFICIAL DISC (P040006/S001) | Depuy Spine, Inc. | 2005-06-16 |
| CHARITE ARTIFICIAL DISC (P040006) | Depuy Spine, Inc. | 2004-10-26 |
| LUMBAR I/F CAGE SYSTEM (P960025/S010) | Depuy Spine, Inc. | 2004-03-17 |
| SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE (P960025/S011) | Depuy Spine, Inc. | 2004-03-05 |