FDA.reportPublic FDA data

Inliant

Primary DI
00850049386111
Brand
Inliant
Company
Navigate Surgical Technologies Inc
Model
900010-1
Catalog number
9000101
Device description
Inliant System, US, Full Package
Published
2023-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLVDental Stereotaxic Instrument
QRYDental Navigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLVDental Stereotaxic InstrumentDental2
QRYDental Navigation SystemDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213392000INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc.2022-02-22PLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049386111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049386111008500493861118500493861110850049386111

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

Contacts#

Phone, Email table
PhoneEmail
16046374497info@navigatesurgical.com

Regulatory Flags#

DUNS number
204920011
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049386029Inliant900007-090000702023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810004900851O Rings for Yomi S TEE Screw Bag of 25NEOCIS INCPLV2026-06-03
00810004900639Yomi S Extra Oral Fiducial Array LLURNEOCIS INCPLV2025-12-01
00810004900646Yomi S Extra Oral Fiducial Array LRULNEOCIS INCPLV2025-12-01
00810004900653Yomi S Intra Oral Fiducial Array SmallNEOCIS INCPLV2025-12-01
00810004900660Yomi S Intra Oral Fiducial Array MediumNEOCIS INCPLV2025-12-01
00810004900677Yomi S Intra Oral Fiducial Array LargeNEOCIS INCPLV2025-12-01
00810004900684Yomi S YomiLink Teeth Posterior LLURNEOCIS INCPLV2025-12-01
00810004900691Yomi S YomiLink Teeth Posterior LRULNEOCIS INCPLV2025-12-01
00810004900707Yomi S YomiLink Arch LLURNEOCIS INCPLV2025-12-01
00810004900714Yomi S YomiLink Arch LRULNEOCIS INCPLV2025-12-01
00810004900721Yomi S YomiLink Teeth Anterior LLURNEOCIS INCPLV2025-12-01
00810004900738Yomi S YomiLink Teeth Anterior LRULNEOCIS INCPLV2025-12-01
00810004900745Yomi S YomiLink Bone Lower LLNEOCIS INCPLV2025-12-01
00810004900752Yomi S YomiLink Bone Lower LRNEOCIS INCPLV2025-12-01
00810004900769Yomi S YomiLink Bone Upper ULNEOCIS INCPLV2025-12-01
00810004900776Yomi S YomiLink Bone (U) Assembly (UR)NEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCQRY2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCPLV2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCQRY2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCQRY2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCQRY2025-12-01
00810004900820Yomi S Draping KitNEOCIS INCPLV2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCPLV2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCQRY2025-12-01
00810004900844Yomi S Starter KitNEOCIS INCPLV2025-12-01
00810004900622Neocis Guidance SystemNEOCIS INCQRY2025-05-02
00817421022920X-GuideXNAV TECHNOLOGIES LLCQRY2024-12-09