Premia Spine Ltd
Country not established
Premia Spine Ltd is a medical device manufacturer, with 498 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II and III) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 498
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 491
- FDA 510(k) 6
- FDA PMA 1
- Device classes
- FDA Class II 431
- FDA Class III 67
- FDA recalls
- Sites and related companies
- Premia Spine Ltd. Israel
- Identifiers
- DUNS 649220779
At a glance
Market reach
- United States
- FDA recalls
What Premia Spine Ltd makes
Premia Spine Ltd manufactures spinal fixation hardware, including cannulated and polyaxial pedicle screws, internal spinal rods, and reusable surgical instruments like guidewires, taps, and distraction tools. Their portfolio also includes reusable orthopaedic and ENT probes, as well as positioning instruments for prosthesis implantation. The company produces torque-limited screwdrivers and reusable surgical handles for spinal and orthopaedic procedures.
The company’s devices are classified under FDA regulations as Class II and Class III, with all products listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States.
Catalogue
Search and filter all 498 devicesShowing 1-50 of 498
Company details
- DUNS number
- 649220779
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 16 Jul 2025 Z-2516-2025 Class II Ongoing Potential for missing pins at tip of inserter.
Sites
- Premia Spine Ltd. ILFEI 3012401682 0 devices
Frequently asked questions
How many devices does PREMIA SPINE LTD have in the registry?
The registry currently lists 498 devices for PREMIA SPINE LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list PREMIA SPINE LTD's devices?
Among its 50 most recently registered devices, PREMIA SPINE LTD has devices listed in FDA GUDID (50 devices).
What risk classes do PREMIA SPINE LTD's devices fall under?
Among its 50 most recently registered devices, the classes recorded for PREMIA SPINE LTD's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for PREMIA SPINE LTD?
FDA recall records list 1 recall initiated by PREMIA SPINE LTD, the most recent initiated on 16 Jul 2025. 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 PREMIA SPINE LTD in the registry?
The most recently registered devices listed for PREMIA SPINE LTD include XL Adaptor 87146, XL Screwdriver CM 89197, Screwdriver CM 89173 and Tube for K-wire over a k-wire technique 470mm (Nitinol) 89289.