K-number	K242914
Device name	Op.n(TM) Navigation
Applicant	Ecential Robotics
Product code	OLO
Device class	Class II
Decision date	Mar 7, 2025
Decision	Substantially Equivalent
Regulation	882.4560

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Op.n Navigation is a surgical guidance system for positioning compatible surgical instruments during general spinal surgery. It uses intra-operative 3D images and navigation software to guide placement of pedicle screws via posterior approach in the thoracolumbar spine region.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Op.n(TM) Navigation

Everything you need for a 510(k) submission. Nothing you don't.