Integrity Implants Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000009805
Integrity Implants Inc. is a medical device manufacturer based in the United States, with 2,181 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I and IIb) and 6 FDA recalls as of 13 Nov 2026.
- Devices
- 2,181
- Registrations
- EUDAMED
- FDA recalls
- 61 ongoing
Registry facts
- Registries
- FDA GUDID 2,174
- EUDAMED 275
- FDA 510(k) 7
- Device classes
- FDA Class II 1,272
- FDA Class I 654
- EU Class I 220
- EU Class IIb 35
- Top EMDN categories
- Orthopaedic and traumatological surgery instruments, reusable 123
- Surgical instruments, reusable - other 52
- Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis 40
- Arthroscopic surgery instruments, reusable 25
- Cardiovascular surgery instruments, reusable 8
- Instruments for functional explorations and therapeutic interventions 4
- FDA recalls
- Sites and related companies
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000009805
- DUNS 080300717
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- MDSS GmbHDE
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.
Catalogue
Search and filter all 2,181 devicesShowing 1-50 of 2,181
Company details
- EUDAMED SRN
- US-MF-000009805
- DUNS number
- 080300717
- EUDAMED status
- Active
- EUDAMED registered name
- Integrity Implants Inc.
- EUDAMED abbreviated name
- Accelus
- Registered address
- 354, Hiatt Drive, 34418, Palm Beach Gardens, United States
- Website
- www.accelusinc.com
- Phone
- +1 561 529 3861
- PRRC contact
- Natalia Giaquinta
FDA recalls
FDA recall records list 6 recalls initiated by Integrity Implants Inc., the earliest on 2018-02-27 and the most recent on 2024-12-20. By recorded status: 1 ongoing and 5 terminated. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 4
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 20 Dec 2024 Z-1008-2025 Class II Ongoing Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
2022
- 3 Aug 2022 Z-0421-2023 Class II Terminated Potential for intraoperative screw head separation at weld location.
- 27 Jan 2022 Z-0418-2023 Class II 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.
- 27 Jan 2022 Z-0419-2023 Class II 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.
- 27 Jan 2022 Z-0420-2023 Class II 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.
2018
- 27 Feb 2018 Z-0405-2019 Class II 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.
Full distribution text
- 27 Feb 2018 Z-0405-2019 Class II 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.
Frequently asked questions
How many devices does Integrity Implants Inc. have in the registry?
The registry currently lists 2181 devices for Integrity Implants Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integrity Implants Inc.'s devices?
Among its 50 most recently registered devices, Integrity Implants Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Integrity Implants Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Integrity Implants Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Integrity Implants Inc.?
FDA recall records list 6 recalls initiated by Integrity Implants Inc., the most recent initiated on 20 Dec 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Integrity Implants Inc. in the registry?
The most recently registered devices listed for Integrity Implants Inc. include FlareHawk FHTPWB5, LineSider ASY-00196, LineSider LS-N6MA5045 and LineSider LS-SC7G1540.