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Sign in to claim this brandIntegrity Implants Inc.
United States·US-MF-000009805
Last updated May 24, 2026
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 5 of 31| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FlareHawk | II-1-0190 | FDA UDI | Class II | Active |
| LineSider | LS-N6RG6540 | FDA UDI | Class II | Active |
| Accelus Navigated Reusable Instruments | ASY-00756 | FDA UDI | Class II | Active |
| FlareHawk | CMP-00109 | FDA UDI | Class II | Active |
| FlareHawk | CMP-00823 | FDA UDI | Class II | Active |
| LineSider | LS-RD50E110 | FDA UDI | Class II | Unknown |
| LineSider | LS-N6CR1570 | FDA UDI | Class II | Active |
| LineSider | LS-N6MA4555 | FDA UDI | Class II | Active |
| LineSider | LS-N6MG9535 | FDA UDI | Class II | Active |
| LineSider | LS-RD55D050 | FDA UDI | Class II | Active |
| LineSider | LS-N6MA6560 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0000 | FDA UDI | Class II | Unknown |
| LineSider | LS-AC5050G2 | FDA UDI | Class II | Active |
| FlareHawk | FHTGCT0925TT | FDA UDI | Class II | Active |
| LineSider | LS-SC7R8590 | FDA UDI | Class II | Active |
| FlareHawk | FHPAS400259S | FDA UDI | Class II | Active |
| LineSider | LS-SC7A5525 | FDA UDI | Class II | Active |
| FlareHawk | FHTPCT0030PTS | FDA UDI | Class II | Active |
| FlareHawk | II-1-0178 | FDA UDI | Class II | Unknown |
| LineSider | LS-RD55D055 | FDA UDI | Class II | Active |
| LineSider | LS-N6SA5540 | FDA UDI | Class II | Active |
| FlareHawk | FHTAS306299S | FDA UDI | Class II | Active |
| LineSider | LS-N6SG5550 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0411 | FDA UDI | Class II | Active |
| LineSider | LS-N6SR7500 | FDA UDI | Class II | Active |
| Accelus Navigated Reusable Instruments | ASY-00759 | FDA UDI | Class II | Active |
| LineSider | LS-N6RA1540 | FDA UDI | Class II | Active |
| LineSider | LS-SC7E5530 | FDA UDI | Class II | Active |
| FlareHawk | II-1-0225 | FDA UDI | Class II | Unknown |
| FlareHawk | FHTACT0029TT | FDA UDI | Class II | Active |
| LineSider | LS-RD55D075 | FDA UDI | Class II | Active |
| LineSider | LS-N6SG8540 | FDA UDI | Class II | Active |
| LineSider | LS-N6RE5050 | FDA UDI | Class II | Active |
| LineSider | LS-N6RA1560 | FDA UDI | Class II | Active |
| LineSider | LS-N6ME4525 | FDA UDI | Class II | Active |
| LineSider | LS-N6SE6555 | FDA UDI | Class II | Active |
| LineSider | LS-N6RA5040 | FDA UDI | Class II | Active |
| LineSider | LS-N6RE5520 | FDA UDI | Class II | Active |
| LineSider | LS-N6CR9570 | FDA UDI | Class II | Active |
| LineSider | LS-N6MA1550 | FDA UDI | Class II | Active |
| LineSider | LS-SC7L5035 | FDA UDI | Class II | Active |
| LineSider | LS-N6RE7540 | FDA UDI | Class II | Active |
| LineSider | LS-RD55F065 | FDA UDI | Class II | Active |
| LineSider | LS-RD55B040 | FDA UDI | Class II | Active |
| LineSider | LS-IC55C35 | FDA UDI | Class II | Active |
| LineSider | LS-N6SE6560 | FDA UDI | Class II | Active |
| LineSider | LS-SC7A5555 | FDA UDI | Class II | Active |
| LineSider | LS-N6RE4550 | FDA UDI | Class II | Active |
| LineSider | LS-N6ME4555 | FDA UDI | Class II | Active |
| LineSider | LS-N6SG6560 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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.
| 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. |