Question 1

Who is the manufacturer of MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM?

Accepted Answer

Dyonics, Inc. filed the 510(k) submission for MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM (K900070).

Question 2

What is the FDA product code for MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM?

Accepted Answer

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

Question 3

When was MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM cleared by the FDA?

Accepted Answer

Feb 16, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODIFIED USES OF THE ARTHROSCOPIC SURGICAL 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	K900070
Device Name	MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM
Applicant	Dyonics, Inc.
Product Code	HRX · Orthopedic
Decision Date	Feb 16, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM

Device Facts

Regulatory Classification

Identification