Pressio, Inc
US Last updated 23 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 9
- Registries
- GUDIDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Continuum PS-01-2012S Ref PS-01-2012S
Continuum PS-01-1812S Ref PS-01-1812S
Continuum PS-01-1412A Ref PS-01-1412A
Continuum PS-01-1812A Ref PS-01-1812A
Continuum PS-01-1612A Ref PS-01-1612A
Continuum PS-01-1612S Ref PS-01-1612S
Continuum PS-01-1412S Ref PS-01-1412S
Continuum PS-01-2012A Ref PS-01-2012A
UNiTi ACDF Implant System Ref K200301
What Pressio, Inc makes
Pressio, Inc manufactures memory-alloy orthopaedic fixation plates, including the Continuum series for spinal stabilization, and the UNiTi ACDF Implant System for anterior cervical discectomy and fusion procedures. These devices are designed to provide rigid or flexible support in spinal surgeries, utilizing shape-memory alloys for adaptive fixation.
The company’s products are classified as Class II medical devices under FDA regulations, with authorisation obtained through 510(k) premarket notifications and listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Pressio, Inc manufacture?
Pressio, Inc specializes in memory-alloy orthopaedic fixation plates. These include the Continuum series, which is used for spinal stabilization, and the UNiTi ACDF Implant System, designed for anterior cervical discectomy and fusion (ACDF) procedures. The devices leverage shape-memory alloys to provide flexible or rigid support during spinal surgeries.
Where is Pressio, Inc based?
Pressio, Inc is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the country.
How are Pressio, Inc’s devices classified under FDA regulations?
Pressio, Inc’s devices are classified as Class II medical devices by the FDA. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as orthopaedic fixation plates. Authorisation for these devices is typically obtained through the 510(k) premarket notification process.
Which regulatory registries or databases list Pressio, Inc’s devices?
Pressio, Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices throughout their lifecycle. Additionally, the company’s products are authorised via 510(k) premarket notifications, ensuring compliance with FDA requirements.
Information
- Country
- US
- Address
- 4600 Lockhill Selma Rd Ste 107, San Antonio, TX, 78249
- Website
- pressiospine.com
- [email protected]
- Phone
- 8666484665
- FDA FEI number
- 3019932366
- DUNS number
- 084706556