Question 1

Who is the manufacturer of TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM?

Accepted Answer

Medicon EG filed the 510(k) submission for TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM (K951689).

Question 2

What is the FDA product code for TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM?

Accepted Answer

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

Question 3

When was TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM cleared by the FDA?

Accepted Answer

Jul 27, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TITANIUM MANDIBULAT RECONSTRUCTION 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	K951689
Device Name	TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM
Applicant	Medicon EG
Product Code	JEY · Dental
Decision Date	Jul 27, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2

TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM

Device Facts

Regulatory Classification

Identification