FDA.reportPublic FDA data

SPINE REFERENCE ARRAY (4 MARKER)

Primary DI
04056481142728
Brand
SPINE REFERENCE ARRAY (4 MARKER)
Company
Brainlab SE
Model
55761A
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212245000Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw PlanningBrainlab AG2022-04-13OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481142728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481142728040564811427284056481142728

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices used during orthopaedic 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 is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314482980
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04056481144821Drill Guide Tube (2.0 mm)51839-202024-06-04
04056481144838Drill Guide Handle518392024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)51839-932024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
07613327631814RPSStryker Leibinger GmbH & Co. KGOLO2025-10-03
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
04056481144906Spine &Trauma NavigationBrainlab SEOLO2024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMABrainlab SEOLO2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMPBrainlab SEOLO2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAYBrainlab SEOLO2024-11-14
04056481144753Drill Guide ArrayBrainlab SEOLO2024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)Brainlab SEOLO2024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)Brainlab SEOLO2024-06-04
04056481144784Drill Guide Tube (4.5 mm)Brainlab SEOLO2024-06-04
04056481144791Drill Guide Tube (3.2 mm)Brainlab SEOLO2024-06-04
04056481144807Drill Guide Tube (2.6 mm)Brainlab SEOLO2024-06-04
04056481144814Drill Guide Tube (2.4 mm)Brainlab SEOLO2024-06-04
04056481144821Drill Guide Tube (2.0 mm)Brainlab SEOLO2024-06-04
04056481144838Drill Guide HandleBrainlab SEOLO2024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)Brainlab SEOLO2024-06-04
04056481145064Drill Guide Trocar Insert (2.4 mm)Brainlab SEOLO2024-06-04
04056481145071Drill Guide Trocar Insert (2.6 mm)Brainlab SEOLO2024-06-04