FDA.reportPublic FDA data

Naviplan

Primary DI
07640176970535
Brand
Naviplan
Company
Naviswiss AG
Model
NS053
Device description
NAVIPLAN, CT Planning Software for Total Hip Replacement
Published
2021-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211429000NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG2021-10-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640176970535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640176970535076401769705357640176970535

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483929829
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640176971327Sizer AdapterNS1322025-11-18
07640176970740Resection CheckerNS0742025-08-12
07640176970016Navigation unitNS0012024-05-16
07640176970023Control unitNS0022024-05-16
07640176970108Set of NAVItags (sterile, single-use)NS0102024-05-16
07640176970115Tag adapter PNS0112024-05-16
07640176970122Tag adapter M (magnetic)NS0122024-05-16
07640176970153Hex screwdriver SW3.5mm (AO coupling)NS0152024-05-16
07640176970177Tag adapter FNS0172024-05-16
07640176970191Pelvic caliperNS0192024-05-16
07640176970214Speed pin (3.0 x 80 mm, wear part)NS0212024-05-16
07640176970221Speed pin adapterNS0222024-05-16
07640176970238Cortical bone screwNS0232024-05-16
07640176970252Calibration barNS0252024-05-16
07640176970306Sterilization tray (254 x 152 x 38 mm)NS0302024-05-16
07640176970320Tag adapter M (quick-lock)NS0322024-05-16
07640176970337PointerNS0332024-05-16
07640176970375Hex screwdriver SW3.5mm spherical headNS0372024-05-16
07640176970467Cortical bone screw (self drilling, 3.5 x 23 mm, wear part)NS0462024-05-16
07640176970481Single-pin tag mount (self-drilling, wear part)NS0482024-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03