Question 1

Who is the manufacturer of SURCAN KNEE HOLDING DEVICE?

Accepted Answer

Bend Orthopedic & Fracture Clinic filed the 510(k) submission for SURCAN KNEE HOLDING DEVICE (K802558).

Question 2

What is the FDA product code for SURCAN KNEE HOLDING DEVICE?

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 SURCAN KNEE HOLDING DEVICE cleared by the FDA?

Accepted Answer

Oct 31, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for SURCAN KNEE HOLDING DEVICE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SURCAN KNEE HOLDING DEVICE?

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	K802558
Device Name	SURCAN KNEE HOLDING DEVICE
Applicant	Bend Orthopedic & Fracture Clinic
Product Code	FWZ · General, Plastic Surgery
Decision Date	Oct 31, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4950
Device Class	Class 1

SURCAN KNEE HOLDING DEVICE

Device Facts

Regulatory Classification

Identification