FDA.reportPublic FDA data

Cirq Robotic Disposable Kinematic Unit

Primary DI
04056481144319
Brand
Cirq Robotic Disposable Kinematic Unit
Company
Brainlab SE
Model
56102-01
Published
2022-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K202320000
K210989000
K221618000
K223864000
K243698000
K252562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202320000CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine SystemBrainlab AG2020-12-23OLO
K210989000Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine SystemBrainlab AG2021-11-12HAW
K221618000Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm SystemBrainlab AG2022-08-30OLO
K223864000Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG2023-09-09HAW
K243698000Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITTBrainlab AG2025-01-28HAW
K252562000Spine & Trauma Navigation InstrumentsBrainlab AG2025-09-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481141677PackageGS15In Commercial Distribution
04056481144319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481141677040564811416774056481141677
04056481144319040564811443194056481144319

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, power-adjustedA device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147099Buzz O.R. Compute179222026-07-09
04056481122751Sterilization Tray Standards Cranial Accessories523152020-10-21
04056481122867Sterilization Tray Frameless Biopsy System523042020-10-21
04056481122874Sterilization Tray Varioguide523032020-10-21
04056481095406STERILIZATION TRAY SPINE BASIC/ANT/UNIV52306A52306A2020-04-02
04056481122812STERILIZATION TRAY HIP REPLACEMENT52309523092020-04-02
04056481122904Sterilization Tray Trauma / Knee Arthroscopy523002020-01-31
04056481122805Sterilization Tray Hip Resurfacing52310523102019-09-27
04056481004835Em Sterilization Tray Basic Instruments18099-08A18099-08A2016-09-15
04056481002718Headband Reference Star - Connector41877-1041877-102016-09-15
04056481003715Mscope Adapter Hs/Moeller Hi-R 700/100041767-8541767-852016-09-15
04056481141363CRANIAL 4PI CT TABLE OVERLAY434302022-05-31
04056481006884ELEMENTS LEAD LOCALIZATION1.026338-022016-11-18
04056481131920Registr. Matrix Imri Ge Headholder19202C19202C2016-09-17
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481144609ExacTrac Dynamic 2.02025-02-19
04056481144654Viewer 5.45.42024-11-05
04056481004101Target Positioner Leksell40700-20A40700-20A2016-09-15
04056481006525Em Disposable Stylet18097180972018-02-08
04056481138769Elements Trajectory Planning2.026250-02C2017-06-14

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Primary DI, Brand, Company table
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00199150067626KIT 9736691 SPINE REFERENCINGMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALLMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORTMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 9736513MEDTRONIC NAVIGATION, INC.OLO2026-08-07
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