Data / Medical devices / United States / Empirical Spine, Inc.
Empirical Spine, Inc.: FDA-registered device maker in Morgan Hill, CA, United States, 1 510(k) clearance and 1 PMA approval
Empirical Spine, Inc. is registered with the FDA (registration 3013114075) in Morgan Hill, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated June 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013114075
- Address
- 18655 Madrone Pkwy Ste 180, Morgan Hill, CA, United States, 95037
- Owner or operator
- Empirical Spine, Inc. (10095318)
- Roles
- Manufacturer
- First device listed
- February 25, 2026
- Registered through
- 2026
- Brand names listed
- Driver, Holder, Instrument Tray, Limiflex Dynamic Sagittal Tether, Limiflex Dynamic Sagittal Tether Driver, Limiflex Dynamic Sagittal Tether Holder, Limiflex Dynamic Sagittal Tether Instrument Tray, Limiflex Dynamic Sagittal Tether Passer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant | SGL | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Spinous Process Tension Band Implant | SGK | 3 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 16, 2026 | K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | SGL | Substantially Equivalent | Empirical Spine | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 12, 2026 | P220031 | LimiFlex Dynamic Sagittal Tether | SGK | 1 | April 8, 2026 | accessdata.fda.gov |
Compare with other makers
Updated June 16, 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.