510(k) Report

FDA applicant

Empirical Spine, Inc.

Morgan Hill2 decisions2026–20260 recalls

FDA records 2 decisions for Empirical Spine, Inc. (Morgan Hill) in 2026: 1 510(k) clearance and 1 original PMA approval. Most are in product codes SGK (Prosthesis, Spinous Process Tension Band Implant) and SGL (Manual Instruments Designed For Use With…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Empirical Spine”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Empirical Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026 (partial year): 2
2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Empirical Spine, Inc. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SGKProsthesis, Spinous Process Tension Band Implant1decision
  • SGLManual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K253374LimiFlex® Dynamic Sagittal Tether Instrument SetEmpirical Spine · 2026
  • P220031LimiFlex Dynamic Sagittal TetherEmpirical Spine, Inc. · 2026

The one decision as Empirical Spine, Inc. →The one decision as Empirical Spine →