Washer
ASNIS - 619990S
Device Description
An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Diameter: 19.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HWC
Device Name: Screw, Fixation, Bone
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 888.3040
Third Party Flag: N
Medical Specialty: OR
Code: OUR
Device Name: Sacroiliac Joint Fixation
Device Class: 2
Physical State: may be used with bone graft, should not be used with bone cement
Definition: sacroiliac joint fusion
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: bridges both sides of the joint, preventing motion
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: sacroiliac joint
Regulation Number: 888.3040
Third Party Flag: N
Medical Specialty: OR
Code: HTN
Device Name: Washer, Bolt Nut
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 888.3030
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 07613327522167
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