Who is the manufacturer of MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT?

Spinalight, Inc. filed the 510(k) submission for MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT (K946258).

What is the FDA product code for MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT?

LXM. as a Class U device in the PM panel.

What is the regulatory pathway for MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT

K946258 · Spinalight, Inc. · LXM · Nov 20, 1995 · PM

Device Facts

Record ID	K946258
Device Name	MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
Applicant	Spinalight, Inc.
Product Code	LXM · PM
Decision Date	Nov 20, 1995
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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