Question 1

Who is the manufacturer of PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

Accepted Answer

Orthomet, Inc. filed the 510(k) submission for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM (K930771).

Question 2

What is the FDA product code for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

Accepted Answer

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

Question 3

When was PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM cleared by the FDA?

Accepted Answer

Nov 30, 1994 (decision: SN).

Question 4

What is the regulatory pathway for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

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	K930771
Device Name	PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
Applicant	Orthomet, Inc.
Product Code	JDI · Orthopedic
Decision Date	Nov 30, 1994
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2

PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM

Device Facts

Regulatory Classification

Identification