Question 1

Who is the manufacturer of INTEGRA FACET FIXATION SYSTEM?

Accepted Answer

Seaspine, Inc. filed the 510(k) submission for INTEGRA FACET FIXATION SYSTEM (K132859).

Question 2

What is the FDA product code for INTEGRA FACET FIXATION SYSTEM?

Accepted Answer

MRW. as a Class U device in the OR panel.

Question 3

When was INTEGRA FACET FIXATION SYSTEM cleared by the FDA?

Accepted Answer

Nov 18, 2013 (decision: SESE).

Question 4

What is the regulatory pathway for INTEGRA FACET FIXATION SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like INTEGRA FACET FIXATION SYSTEM?

Accepted Answer

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.

Record ID	K132859
Device Name	INTEGRA FACET FIXATION SYSTEM
Applicant	Seaspine, Inc.
Product Code	MRW · OR
Decision Date	Nov 18, 2013
Decision	SESE
Submission Type	Traditional
Device Class	Class U

INTEGRA FACET FIXATION SYSTEM

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