Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Integrity Implants with 12 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated May 21, 2025: FlareHawk Interbody Fusion System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 21, 2025 | FlareHawk Interbody Fusion SystemK243116 · MAX | 510(k) clearances |
| Dec 20, 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The RepeaterClass II · Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). | Device recalls |
| Aug 7, 2023 | LineSider® Spinal SystemK231098 · NKB | 510(k) clearances |
| Aug 3, 2022 | LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. ThoracoClass II · Potential for intraoperative screw head separation at weld location. | Device recalls |
| Mar 25, 2022 | Toro-L Interbody Fusion SystemK213355 · MAX | 510(k) clearances |
| Mar 24, 2022 | FlareHawk Interbody Fusion SystemK220453 · MAX | 510(k) clearances |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlamClass II · Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result | Device recalls |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal Class II · Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result | Device recalls |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal inteClass II · Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result | Device recalls |
| Dec 23, 2021 | Integrity Implants Navigated InstrumentsK212088 · OLO | 510(k) clearances |
| Mar 26, 2021 | Toro-L Interbody Fusion SystemK203038 · MAX | 510(k) clearances |
| Dec 3, 2020 | LineSider™ Spinal SystemK203367 · NKB | 510(k) clearances |
| Nov 3, 2020 | FlareHawk Interbody Fusion SystemK202198 · MAX | 510(k) clearances |
| Feb 27, 2018 | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated forClass II · Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. Th | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
