LineSider™ Spinal System
FDA 510(k) clearance K203367 · decided 2020-12-03
Clearance details
- K-number
- K203367
- Device name
- LineSider™ Spinal System
- Applicant
- Integrity Implants, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-16
- Decision date
- 2020-12-03
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Tho recall (Z-0418-2023) | Integrity Implants Inc. | 2022-12-05 |
| LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoraco recall (Z-0419-2023) | Integrity Implants Inc. | 2022-12-05 |
| LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbo recall (Z-0420-2023) | Integrity Implants Inc. | 2022-12-05 |
| LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non recall (Z-0421-2023) | Integrity Implants Inc. | 2022-12-05 |