FDA.reportPublic FDA data

Elements Trajectory Planning

Primary DI
04056481138769
Brand
Elements Trajectory Planning
Company
Brainlab SE
Model
2.0
Catalog number
26250-02C
Published
2017-06-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K113732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113732000IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)Brainlab AG2012-05-07JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481000257PreviousGS10
04056481138769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481000257040564810002574056481000257
04056481138769040564811387694056481138769

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Contacts#

Phone, Email table
PhoneEmail
+49899915680contact@brainlab.com

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481146207Spine Planning3.02026-10-23
04056481144609ExacTrac Dynamic2.02025-02-19
04056481147112RT Elements4.72026-10-22
04056481147969Spine and Trauma Navigation3.12026-10-19
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481144906Spine &Trauma Navigation3.02024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMA55761B2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMP55761-01B2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY52419A2024-11-14
04056481144753Drill Guide Array51839-032024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)51839-022024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)51839-012024-06-04
04056481144784Drill Guide Tube (4.5 mm)51839-452024-06-04
04056481144791Drill Guide Tube (3.2 mm)51839-322024-06-04
04056481144807Drill Guide Tube (2.6 mm)51839-262024-06-04
04056481144814Drill Guide Tube (2.4 mm)51839-242024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20