FDA.reportPublic FDA data

X-Guide

Primary DI
00817421021350
Brand
X-Guide
Company
XNAV TECHNOLOGIES LLC
Model
P010304
Catalog number
P010304
Device description
BONE SCREW, EDX - 2.7Ø x 8mm
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
00817421021367PackageGS12In Commercial Distribution
00817421022692PackageGS12In Commercial Distribution
00817421021350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817421021367008174210213678174210213670817421021367
00817421022692008174210226928174210226920817421022692
00817421021350008174210213508174210213500817421021350

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
00817421021411X-GuideP010307P0103072021-01-25
00817421021336X-GuideP010303P0103032021-01-25
00817421021374X-GuideP010305P0103052021-01-25
00817421021398X-GuideP010306P0103062021-01-25
00817421021435X-GuideP010308P0103082021-01-25
00817421021190X-GuideP0108572021-01-25
00817421021206X-GuideP0108602021-01-25
00817421021213X-GuideP0108692021-01-25
00817421021220X-GuideP0108702021-01-25
00817421021251X-GuideP0108732021-01-25
00817421021268X-GuideP0108742021-01-25
00817421022883FastMapP0120032025-01-31
00817421022920X-GuideP0085422024-12-09
00817421023361X-GuideP0085422024-12-09
00817421022852X-Guide FastMapP0119422024-06-24
00817421022791X-GuideP0118032024-10-08
00817421022784X-GuideP0085422024-09-06
00817421022814X-GuideP0085422024-09-06
00817421022821X-GuideP0085422024-09-06
00817421022753X-GuideP0085422024-09-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800089458905Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458936Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458943Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458950Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458974Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
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ESAM23060131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM21221001STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23053141STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
10810004515700CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515748CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515755CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515762CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515779CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515786CMF VISIONAREVISIONARE, LLCDZL2019-02-21