Acme Spine, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Acme Spine, LLC makes
Acme Spine, LLC manufactures spinal fixation systems, including monoaxial and polyaxial screw assemblies (Series 6000, 7000) and the Acme Talon pedicle screw, designed for internal spinal stabilization procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Acme Talon Pedicle Screw Ref K071824
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Acme Spine, LLC have in the registry?
The registry currently lists 2 devices for Acme Spine, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acme Spine, LLC's devices?
Among its 2 most recently registered devices, Acme Spine, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Acme Spine, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Acme Spine, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acme Spine, LLC in the registry?
The most recently registered devices listed for Acme Spine, LLC include ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM and ACME TALON PEDICLE SCREW.