Question 1

Who is the manufacturer of HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

Accepted Answer

Onyx Medical Corp. filed the 510(k) submission for HANSEN-STREET TYPE INTRAMEDULLARY NAIL (K903256).

Question 2

What is the FDA product code for HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

Accepted Answer

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

Question 3

When was HANSEN-STREET TYPE INTRAMEDULLARY NAIL cleared by the FDA?

Accepted Answer

Jul 30, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

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	K903256
Device Name	HANSEN-STREET TYPE INTRAMEDULLARY NAIL
Applicant	Onyx Medical Corp.
Product Code	HSB · Orthopedic
Decision Date	Jul 30, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2

HANSEN-STREET TYPE INTRAMEDULLARY NAIL

Device Facts

Regulatory Classification

Identification