FDA.reportPublic FDA data

Inliant

Primary DI
00850049386029
Brand
Inliant
Company
Navigate Surgical Technologies Inc
Model
900007-0
Catalog number
9000070
Device description
Consumable - Fiducial Kit
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLVDental Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLVDental Stereotaxic InstrumentDental2

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
00850049386029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049386029008500493860298500493860290850049386029

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
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049386111Inliant900010-190001012023-09-05

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
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCPLV2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCPLV2025-12-01
00810004900820Yomi S Draping KitNEOCIS INCPLV2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCPLV2025-12-01
00810004900844Yomi S Starter KitNEOCIS INCPLV2025-12-01
00817421022920X-GuideXNAV TECHNOLOGIES LLCPLV2024-12-09
00817421023361X-GuideXNAV TECHNOLOGIES LLCPLV2024-12-09
00817421022791X-GuideXNAV TECHNOLOGIES LLCPLV2024-10-08
00817421022784X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-06
00817421022814X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-06
00817421022821X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-06
00817421022753X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-05