Question 1

Who is the manufacturer of HALL DUNBAR DRILL GUIDE SYSTEM?

Accepted Answer

Hall Surgical, Division of Zimmer, Inc. filed the 510(k) submission for HALL DUNBAR DRILL GUIDE SYSTEM (K864163).

Question 2

What is the FDA product code for HALL DUNBAR DRILL GUIDE 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 HALL DUNBAR DRILL GUIDE SYSTEM cleared by the FDA?

Accepted Answer

Nov 20, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for HALL DUNBAR DRILL GUIDE SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HALL DUNBAR DRILL GUIDE 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	K864163
Device Name	HALL DUNBAR DRILL GUIDE SYSTEM
Applicant	Hall Surgical, Division of Zimmer, Inc.
Product Code	HRX · Orthopedic
Decision Date	Nov 20, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

HALL DUNBAR DRILL GUIDE SYSTEM

Device Facts

Regulatory Classification

Identification