Question 1

Who is the manufacturer of INTRAMEDULLARY SYSTEMS?

Accepted Answer

Baumer Ortopedia , Ltd. filed the 510(k) submission for INTRAMEDULLARY SYSTEMS (K930972).

Question 2

What is the FDA product code for INTRAMEDULLARY SYSTEMS?

Accepted Answer

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

Question 3

When was INTRAMEDULLARY SYSTEMS cleared by the FDA?

Accepted Answer

Mar 29, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for INTRAMEDULLARY SYSTEMS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like INTRAMEDULLARY SYSTEMS?

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	K930972
Device Name	INTRAMEDULLARY SYSTEMS
Applicant	Baumer Ortopedia , Ltd.
Product Code	HSB · Orthopedic
Decision Date	Mar 29, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2

INTRAMEDULLARY SYSTEMS

Device Facts

Regulatory Classification

Identification