Question 1

Who is the manufacturer of DURACON STABILIZER FEMORAL COMPONENT AND INSERT?

Accepted Answer

Howmedica Corp. filed the 510(k) submission for DURACON STABILIZER FEMORAL COMPONENT AND INSERT (K932070).

Question 2

What is the FDA product code for DURACON STABILIZER FEMORAL COMPONENT AND INSERT?

Accepted Answer

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

Question 3

When was DURACON STABILIZER FEMORAL COMPONENT AND INSERT cleared by the FDA?

Accepted Answer

Mar 22, 1995 (decision: SN).

Question 4

What is the regulatory pathway for DURACON STABILIZER FEMORAL COMPONENT AND INSERT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DURACON STABILIZER FEMORAL COMPONENT AND INSERT?

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	K932070
Device Name	DURACON STABILIZER FEMORAL COMPONENT AND INSERT
Applicant	Howmedica Corp.
Product Code	JWH · Orthopedic
Decision Date	Mar 22, 1995
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2

DURACON STABILIZER FEMORAL COMPONENT AND INSERT

Device Facts

Regulatory Classification

Identification