FDA.reportPublic FDA data

X-Guide

Primary DI
00817421021374
Brand
X-Guide
Company
XNAV TECHNOLOGIES LLC
Model
P010305
Catalog number
P010305
Device description
BONE SCREW, EDX - 2.7Ø x 16mm
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZLScrew, Fixation, Intraosseous
QRYDental Navigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2
QRYDental Navigation SystemDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150222000
K200662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150222000X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2015-10-08PLV
K200662000X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC2020-05-21PLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817421021381PackageGS12In Commercial Distribution
00817421022708PackageGS12In Commercial Distribution
00817421021374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817421021381008174210213818174210213810817421021381
00817421022708008174210227088174210227080817421022708
00817421021374008174210213748174210213740817421021374

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
026096247
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817421023668X-GuideP0112652026-10-14
00817421023675X-GuideP0112662026-10-14
00817421023682X-GuideP0112682026-10-14
00817421023699X-GuideP0112692026-10-14
00817421023705X-GuideP0112712026-10-14
00817421023712X-GuideP0112722026-10-14
00817421023729X-GuideP0116932026-10-14
00817421023736X-GuideP0116942026-10-14
00817421023743X-GuideP0116962026-10-14
00817421023750X-GuideP0116972026-10-14
00817421023767X-GuideP0121262026-10-14
00817421023774X-GuideP0121272026-10-14
00817421023781X-GuideP0121282026-10-14
00817421023798X-GuideP0121292026-10-14
00817421023323X-GuideP0115582026-10-13
00817421023354X-GUIDEP0115482026-10-13
00817421023545X-GUIDEP0123612026-10-13
00817421023552X-GUIDEP0115432026-10-13
00817421023569X-GUIDEP0115442026-10-13
00817421023576X-GUIDEP0115452026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817421023668X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023668X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023675X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023675X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023682X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023682X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023699X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023699X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023705X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023705X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023712X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023712X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023729X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023729X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023736X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023736X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023743X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023743X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023750X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023750X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023767X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023767X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023774X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023774X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023781X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023781X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-14
00817421023798X-GuideXNAV TECHNOLOGIES LLCDZL2026-10-14
00817421023323X-GuideXNAV TECHNOLOGIES LLCQRY2026-10-13
00817421023354X-GUIDEXNAV TECHNOLOGIES LLCQRY2026-10-13