Question 1

Who is the manufacturer of MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER?

Accepted Answer

Mcconnell Orthopedic filed the 510(k) submission for MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER (K871819).

Question 2

What is the FDA product code for MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER?

Accepted Answer

FWZ. It is classified under 21 CFR 878.4950 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER cleared by the FDA?

Accepted Answer

May 22, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER?

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	K871819
Device Name	MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER
Applicant	Mcconnell Orthopedic
Product Code	FWZ · General, Plastic Surgery
Decision Date	May 22, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4950
Device Class	Class 1

MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER

Device Facts

Regulatory Classification

Identification