510(k) K203367 · NKB Thoracolumbosacral Pedicle Screw System
LineSider Spinal System
| Applicant | Integrity Implants, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Dec 3, 2020 |
| Received | Nov 16, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and Terminated |
NKB | None listed |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545.
Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation Terminated |
NKB | None listed |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shi Terminated |
NKB | None listed |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.