Data / Medical devices / United States / Elevation Spine
Elevation Spine: FDA-registered device maker in Monterey, CA, United States, 1 510(k) clearance
Elevation Spine is registered with the FDA (registration 3015991317) in Monterey, CA, United States. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015991317
- Address
- 2511 Garden Road Suite B125, Monterey, CA, United States, 93940
- Owner or operator
- Elevation Spine (10061171)
- Roles
- Specification developer
- First device listed
- September 4, 2019
- Registered through
- 2026
- Brand names listed
- Assembly tool, Awl, Straight, Carriage 10mm, Carriage 5-6mm, Carriage 7mm, Carriage 8mm, Carriage 9mm, Drill, Straight and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | 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 |
|---|---|---|---|---|---|---|
| August 7, 2019 | K190885 | Elevation Spine Saber-C System | OVE | Substantially Equivalent | Elevation Spine | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Mallet
- All makers of Template
- All makers of Bit, Drill
- All makers of Awl
- All makers of Wrench
Updated August 7, 2019. 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.