Question 1

Who is the manufacturer of P.F.C. BIPOLAR HIP SYSTEM?

Accepted Answer

Johnson & Johnson Orthopaedics, Inc. filed the 510(k) submission for P.F.C. BIPOLAR HIP SYSTEM (K931655).

Question 2

What is the FDA product code for P.F.C. BIPOLAR HIP SYSTEM?

Accepted Answer

KWY. It is classified under 21 CFR 888.3390 as a Class 2 device in the Orthopedic panel.

Question 3

When was P.F.C. BIPOLAR HIP SYSTEM cleared by the FDA?

Accepted Answer

Jun 9, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for P.F.C. BIPOLAR HIP SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like P.F.C. BIPOLAR HIP 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	K931655
Device Name	P.F.C. BIPOLAR HIP SYSTEM
Applicant	Johnson & Johnson Orthopaedics, Inc.
Product Code	KWY · Orthopedic
Decision Date	Jun 9, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3390
Device Class	Class 2

P.F.C. BIPOLAR HIP SYSTEM

Device Facts

Regulatory Classification

Identification