Empirical Spine: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Empirical Spine” (first 2026, latest 2026), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 259 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 259 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Empirical Spine took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 259 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SGK | Prosthesis, Spinous Process Tension Band Implant | 1 | 0 |
| SGL | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Empirical Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | SGL | 2026-06-16 | 259 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220031 | PMA | LimiFlex Dynamic Sagittal Tether | 2026-02-12 |
Recalls
openFDA lists no recalls under a recalling firm named Empirical Spine.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Empirical Spine is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03115983: LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis (Active not recruiting, started 2017-07-17)
Frequently asked questions
How many FDA 510(k) clearances are listed under Empirical Spine?
FDA lists 1 510(k) clearance under the applicant name “Empirical Spine” (first 2026, latest 2026), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Empirical Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Empirical Spine is 259 days.
Which FDA product codes appear under Empirical Spine?
The most frequent FDA product codes under this applicant name are SGK (Prosthesis, Spinous Process Tension Band Implant, 1); SGL (Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant, 1).
Next steps
- See all 1 Empirical Spine clearances with predicates and recalls
- Run predicate analysis for product code SGK, Empirical Spine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.