Data / Medical devices / United States / Alphatec Spine, Inc.
Alphatec Spine, Inc.: FDA-registered device maker in Louisville, CO, United States, 6 510(k) clearances
Alphatec Spine, Inc. is registered with the FDA (registration 3015537048) in Louisville, CO, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 19, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015537048
- Address
- 168 Centennial Parkway Unit 170, Louisville, CO, United States, 80027
- Owner or operator
- ALPHATEC HOLDINGS, INC. (9072657)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- July 20, 1999
- Registered through
- 2027
- Brand names listed
- Orthopedic Manual Surgical Instrument, Remi Robotic Navigation System, Sterilization Container used with Remi Robotic Navigation System, Valence Robotic Navigation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 19, 2026 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 8, 2023 | K232413 | Fusion Robotic Navigation System | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 13, 2023 | K223350 | Remi Robotic Navigation System | OLO | Substantially Equivalent | Fusion Robotics, LLC | accessdata.fda.gov |
| October 28, 2022 | K223070 | Remi Robotic Navigation System | OLO | Substantially Equivalent | Fusion Robotics, LLC | accessdata.fda.gov |
| February 24, 2021 | K202184 | Practical Navigation Surgical Guidance System (PNSGS) | OLO | Substantially Equivalent | Practical Navigation, LLC | accessdata.fda.gov |
| May 4, 2012 | K112671 | STERILCONTAINER SYSTEM | KCT | Substantially Equivalent | Aesculap, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Orthopedic Manual Surgical Instrument
Updated February 19, 2026. 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.