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Ear, Nose, And Throat Stereotaxic Instrument

FDA product code PGW · 33 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4560
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-02-18 – 2026-09-04

Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

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