FDA.reportPublic FDA data

Automatic Registration

Primary DI
04056481142414
Brand
Automatic Registration
Company
Brainlab SE
Model
2.5
Published
2021-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192703000
K203679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192703000Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure UpdateBrainlab AG2020-10-08HAW
K203679000Automatic RegistrationBrainlab AG2021-03-18OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481142414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481142414040564811424144056481142414

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

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00887868557873ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557880ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557897ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557903ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557910ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558078ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558092ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558146ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558160ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558177ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558306ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575105ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575112ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575129ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575136ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575143ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575150ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575167ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575174ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575181ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868580963ROSA® ShoulderOrthosoft IncOLO2024-03-06