Integrity Implants Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 11
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1008-2025 | Class II | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version | December 20, 2024 |
| Z-0421-2023 | Class II | LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulate | August 3, 2022 |
| Z-0418-2023 | Class II | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbo | January 27, 2022 |
| Z-0419-2023 | Class II | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacr | January 27, 2022 |
| Z-0420-2023 | Class II | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pe | January 27, 2022 |
| Z-0405-2019 | Class II | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (I | February 27, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231098 | LineSider® Spinal System | August 7, 2023 |
| K213355 | Toro-L Interbody Fusion System | March 25, 2022 |
| K220453 | FlareHawk Interbody Fusion System | March 24, 2022 |
| K212088 | Integrity Implants Navigated Instruments | December 23, 2021 |
| K203038 | Toro-L Interbody Fusion System | March 26, 2021 |
| K203367 | LineSider Spinal System | December 3, 2020 |
| K202198 | FlareHawk Interbody Fusion System | November 3, 2020 |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | September 23, 2020 |
| K190360 | LineSider Spinal System | June 21, 2019 |
| K183184 | FlareHawk Interbody Fusion System | April 3, 2019 |
| K182114 | FlareHawk Interbody Fusion System | January 7, 2019 |