TRIAL 77367456 DIVERGE 6 DEG 5
DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM - 77367456
Device Description
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
- 6DEG 5-6mm x 17mm x 14mm
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: KWQ
Device Name: Appliance, Fixation, Spinal Intervertebral Body
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: 888.3060
Third Party Flag: N
Medical Specialty: OR
Code: ODP
Device Name: Intervertebral Fusion Device With Bone Graft, Cervical
Device Class: 2
Physical State: Hollow cylinder or rectangular box made of metal or polymer.
Definition: Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Acts as a disc spacer and holds bone graft.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Intervertebral disc space.
Regulation Number: 888.3080
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00643169516182
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
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