Who is the manufacturer of GAMMA SYSTEM?

Zimmer, Inc. submitted the Traditional clearance for GAMMA SYSTEM (K955473).

What is the FDA product code for GAMMA SYSTEM?

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for GAMMA SYSTEM?

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

GAMMA SYSTEM

K955473 · Zimmer, Inc. · JDI · Feb 16, 1996 · Orthopedic

Device Facts

Record ID	K955473
Device Name	GAMMA SYSTEM
Applicant	Zimmer, Inc.
Product Code	JDI · Orthopedic
Decision Date	Feb 16, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).