Question 1

Who is the manufacturer of HALL MODULAR ACETABULAR REAMER SYSTEM?

Accepted Answer

Zimmer, Inc. filed the 510(k) submission for HALL MODULAR ACETABULAR REAMER SYSTEM (K902332).

Question 2

What is the FDA product code for HALL MODULAR ACETABULAR REAMER SYSTEM?

Accepted Answer

HWE. It is classified under 21 CFR 878.4820 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was HALL MODULAR ACETABULAR REAMER SYSTEM cleared by the FDA?

Accepted Answer

Jun 25, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for HALL MODULAR ACETABULAR REAMER SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HALL MODULAR ACETABULAR REAMER 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	K902332
Device Name	HALL MODULAR ACETABULAR REAMER SYSTEM
Applicant	Zimmer, Inc.
Product Code	HWE · General, Plastic Surgery
Decision Date	Jun 25, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4820
Device Class	Class 1

HALL MODULAR ACETABULAR REAMER SYSTEM

Device Facts

Regulatory Classification

Identification