Data / Medical devices / United States / Unified Spine, LLC
Unified Spine, LLC: FDA-registered device maker in Westerville, OH, United States, 6 510(k) clearances
Unified Spine, LLC is registered with the FDA (registration 3006215390) in Westerville, OH, United States. It lists 16 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 11, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006215390
- Address
- 6295 Maxtown Road Suite #500, Westerville, OH, United States, 43082
- Owner or operator
- Unified Spine, LLC (10083837)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 2021
- Registered through
- 2026
- Brand names listed
- GSO ACP1 Anterior Cervical Plate System, GSO GS1 Cannulated Screw System, GSO PCT Spinal System, Gso Bone Fixation Fasteners, Gso GS1 Spinal System, Gso Gs1 Spacer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2013 | K123487 | GSO GS1 CANNULATED SCREW SYSTEM | MNH | Substantially Equivalent | Gold Standard Orthopaedics, LLC | accessdata.fda.gov |
| July 25, 2011 | K110990 | GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Gold Standard Orthopedics, LLC | accessdata.fda.gov |
| September 2, 2009 | K091359 | GSO PCT SPINAL SYSTEM | KWP | Substantially Equivalent | Gold Standard Orthopaedics, LLC | accessdata.fda.gov |
| August 24, 2007 | K071274 | GSO GS1 SPACER | MQP | Substantially Equivalent | Gold Standard Orthopedics, LLC | accessdata.fda.gov |
| July 20, 2007 | K070966 | GSO GS1 SPINAL SYSTEM | KWP | Substantially Equivalent | Gold Standard Orthopaedics, LLC | accessdata.fda.gov |
| January 31, 2007 | K063589 | GSO BONE FIXATION FASTENERS | HWC | Substantially Equivalent | Gold Standard Orthopaedics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Bit, Drill
- All makers of Tap, Bone
- All makers of Screwdriver
- All makers of Awl
- All makers of Instrument, Bending Or Contouring
Updated March 11, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.