Phase I
Risk document created in Phase I
What is the Risk Plan?
Main quality deliverable in Phase II
What is the Quality Plan?
Name an ASTM testing standard used for plating systems.
What is ASTM F1717?
These ATEC devices that are usually direct part marking exempt.
What are implants and single use instruments?
List the goals of spine surgery
What are decompression, stabilization, and alignment?
During Phase I, ________ and ________ must be established for a product
What is User Needs and Design Inputs?
Minimum size for Lasermarking (human readable)
What is 0.8 mm?
ISO standard used to classify materials in Biocompatibility documents.
What is ISO 10993?
Last document to be released before regulatory holds can be released.
What is the phase IV sign off checklist?
The thoracic spine has how many vertebrae?
What is 12?
User needs must be able to be _______
What is validated?
For Instruments, this Lasermarking takes precedence over all other Lasermarking.
What is Lot Number?
List all 4 SKIF types
What is: Sterilization Case, Demo/LAb, Tote/Kit, OEM
Bonus: Caddy
This document must be uploaded to the ATEC website before regulatory holds are released.
What is the IFU?
Scoliosis is defined as spinal curvature in this plane.
What is coronal?
Document that describes the approach for getting FDA clearance for a device.
What is the Regulatory Affairs Strategic Plan?
Name the 3 types of documents that are considered design outputs.
What is: Engineering Drawings, Specifications, and Procurement Specifications?
Which document needs to be routed with the SKIF if additional parts are being added to the SKIF?
What is Sterilization Validation?
The risk report contains this type of analysis
What is a risk/benefit analysis?
The 3 properties needed to facilitate bone growth.
What is: Osteoinductive, Osteoconductive and Osteogenic?
This routes on the same CO as the Phase Sign Off check list.
What is the Agile eDHF Linking?
Name the 3 software specific documents for Phase II.
What is: Software Design Specification, Software Architecture, System Configuration Status Report?
Which document discusses the relevant test modes for a device and provides testing rationale and justifications?
What is the Worst Case Rationale?
Number of surgeon evaluators needed for higher risk devices.
What is 3?
Removal of a portion of the lamina
What is a laminotomy?