INSTRUMENT SET, AVANTA CMC
Avanta CMC - CMC-S
Device Description
A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: KWG
Device Name: Prosthesis, Finger, Constrained, Metal/Polymer
Device Class: 3
Physical State: N/A
Definition: Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Submission Type ID: 2
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3220
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00886385025780
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A