Order Catalog Implementation Guide
1.0.0-ballot - CI Build
Order Catalog Implementation Guide
1.0.0-ballot - CI Build
Order Catalog Implementation Guide, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
Language: en-US
Profile: Device Model
Reference to a catalog: Composition Worldwide Device Catalog
description:
12mm, 10degree Lateral Interbody Fusion, 22x60mm, PEEK Implant Assembly
identifier: Universal Device Identifier/00843210101415 (use: secondary, )
udiDeviceIdentifier
deviceIdentifier: B417F12260121
issuer: urn:oid:2.16.840.1.113883.6.40
jurisdiction: urn:oid:2.16.840.1.113883.3.150
MarketDistributions
MarketPeriod SubJurisdiction 2017-08-22 --> (ongoing) urn:oid:2.16.840.1.113883.3.150
manufacturer: Altus Spine, LLC
| Name | Type |
| Imola Interbody Fusion System | Registered name |
modelNumber: F12260-12
classification
type: Polymeric spinal interbody fusion cage
classification
type: Spinal cage
classification
type: Spinal fusion systems
safety: Labeling does not Contain MRI Safety Information
languageCode: English (United States)
property
type: For single use
value: true
property
type: Prescription use
value: true
property
type: Over the counter
value: false
property
type: Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
value: false
property
type: Length
value: 60 millimeter (Details: UCUM codemm = 'mm')
property
type: Width
value: 22 millimeter (Details: UCUM codemm = 'mm')
property
type: Heigth
value: 12 millimeter (Details: UCUM codemm = 'mm')
property
type: Angle
value: 10 degree (Details: UCUM codedeg = 'deg')
contact: Info@altus-spine.com
guideline
relatedArtifact
type: Documentation
label: Device described in GUDID:
Documents
Url https://accessgudid.nlm.nih.gov/devices/B417F12260121
IG © 2021+ HL7 International / Orders and Observations. Package hl7.fhir.uv.order-catalog#1.0.0-ballot based on FHIR 5.0.0. Generated 2025-06-12
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change