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Sign in to claim this brandIntegrity Implants Inc.
United States·US-MF-000009805
Last updated May 24, 2026
What Integrity Implants Inc. makes
Integrity Implants Inc. manufactures spinal fixation hardware, including non-bioabsorbable bone screws, metallic and polymer-based interbody fusion cages, reusable bone taps, and spinal fixation rods and connectors. Their product line also includes reusable surgical screwdrivers designed for spinal procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Integrity Implants Inc. manufacture?
Integrity Implants Inc. specializes in spinal fixation hardware, including non-bioabsorbable bone screws, metallic and polymer-based spinal interbody fusion cages, reusable bone taps, and components for internal spinal fixation systems like rods and connectors. Their product line also includes reusable surgical screwdrivers tailored for spinal surgical procedures. These devices are designed to support spinal stability and fusion.
Where is Integrity Implants Inc. based?
Integrity Implants Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as it operates under the jurisdiction of the FDA, which governs medical device authorization in the US.
Which regulatory registries list devices manufactured by Integrity Implants Inc.?
Devices from Integrity Implants Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized identification for medical devices, ensuring traceability and transparency in regulatory tracking. This listing helps healthcare providers and regulators verify device details.
How are devices from Integrity Implants Inc. classified under FDA regulations?
Integrity Implants Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny applied to each device type.
What is the purpose of the reusable bone taps and surgical screwdrivers produced by Integrity Implants Inc.?
The reusable bone taps and surgical screwdrivers from Integrity Implants Inc. are designed to assist in spinal surgical procedures. Bone taps create precise channels in vertebrae for screws or implants, while the screwdrivers provide controlled insertion or removal of spinal fixation hardware. Their reusable design aims to enhance efficiency and reduce waste in operating environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 354, Hiatt Drive, Palm Beach Gardens, United States
- Website
- www.accelusinc.com
- —
- —
- [email protected]
- Phone
- +1 561 529 3861
- PRRC Contact
- Natalia Giaquinta
- EUDAMED SRN
- US-MF-000009805
- FDA FEI Number
- —
- DUNS Number
- 080300717
Catalogue (1530)
Page 10 of 31| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FlareHawk | II-1-0455 | FDA UDI | Class II | Active |
| Accelus Navigated Reusable Instruments | ASY-00753 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0248 | FDA UDI | Class II | Unknown |
| FlareHawk | II-1-0180 | FDA UDI | Class II | Unknown |
| LineSider | LS-SC7R9580 | FDA UDI | Class II | Active |
| FlareHawk | FHTPCS0026TT | FDA UDI | Class II | Active |
| LineSider | LS-SC7G7540 | FDA UDI | Class II | Active |
| LineSider | LS-N6SA7555 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG9545 | FDA UDI | Class II | Active |
| LineSider | LS-N6SE4530 | FDA UDI | Class II | Active |
| LineSider | LS-N6MA9550 | FDA UDI | Class II | Active |
| Accelus Navigated Reusable Instruments | ASY-00735 | FDA UDI | Class II | Active |
| LineSider | LS-N6SE5030 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG1545 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0108 | FDA UDI | Class II | Unknown |
| FlareHawk | FHTPCT0026TTS | FDA UDI | Class II | Active |
| LineSider | LS-N6SE5535 | FDA UDI | Class II | Active |
| LineSider | LS-N6SR1570 | FDA UDI | Class II | Active |
| LineSider | LS-AC6063A1 | FDA UDI | Class II | Active |
| LineSider | LS-RD60C085 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG5025 | FDA UDI | Class II | Active |
| FlareHawk | FHTAS10627O | FDA UDI | Class II | Active |
| LineSider | LS-N6SE6550 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG5545 | FDA UDI | Class II | Active |
| LineSider | LS-SC7A5550 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0113 | FDA UDI | Class II | Unknown |
| LineSider | LS-SC7A9555 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0194 | FDA UDI | Class II | Active |
| LineSider | ASY-01129 | FDA UDI | Class II | Active |
| FlareHawk | FHPAS206259S | FDA UDI | Class II | Active |
| LineSider | LS-N6SA8550 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG8555 | FDA UDI | Class II | Active |
| LineSider | LS-N6SA5525 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG4530 | FDA UDI | Class II | Active |
| LineSider | LS-SC7E7540 | FDA UDI | Class II | Active |
| LineSider | LS-N6SG5535 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0412 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0169 | FDA UDI | Class II | Unknown |
| LineSider | LS-N6SG8550 | FDA UDI | Class II | Active |
| LineSider | LS-N6MA7540 | FDA UDI | Class II | Active |
| LineSider | LS-RD50G200 | FDA UDI | Class II | Unknown |
| LineSider | LS-RD60C035 | FDA UDI | Class II | Active |
| LineSider | LS-N6SA9535 | FDA UDI | Class II | Active |
| LineSider | LS-N6SE5050 | FDA UDI | Class II | Active |
| LineSider | LS-SC7A5050 | FDA UDI | Class II | Active |
| LineSider | LS-N6SA1560 | FDA UDI | Class II | Active |
| LineSider | LS-N6RA8555 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0454 | FDA UDI | Class II | Active |
| LineSider | LS-N6RA6525 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG5030 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Integrity Implants Inc. has six FDA recall records initiated between February 27, 2018, and December 20, 2024. The records include instances of potential weld separation in components (noted in two records), a field correction for discrepancies in cleaning parameters in labeling material, and a compatibility issue between specific bone tamp and bone funnel revisions. The recall statuses listed are open, classified, and terminated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 20, 2024 | Z-1008-2025 | — | open, classified | Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). |
| Aug 3, 2022 | Z-0421-2023 | — | terminated | Potential for intraoperative screw head separation at weld location. |
| Jan 27, 2022 | Z-0418-2023 | — | terminated | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. |
| Jan 27, 2022 | Z-0420-2023 | — | terminated | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. |
| Jan 27, 2022 | Z-0419-2023 | — | terminated | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. |
| Feb 27, 2018 | Z-0405-2019 | — | terminated | Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts. |