FDA.reportPublic FDA data

Curve™

Primary DI
04056481006365
Brand
Curve™
Company
Brainlab SE
Model
19901
Catalog number
19901
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K092467000
K183605000
K221618000
K243698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092467000VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITEDBrainlab AG2010-05-06HAW
K183605000Spine & Trauma NavigationBrainlab AG2019-08-29OLO
K221618000Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm SystemBrainlab AG2022-08-30OLO
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481006365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481006365040564810063654056481006365

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

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481145804Brainlab Origin OR1.02026-08-21
04056481006525Em Disposable Stylet18097180972018-02-08
04056481141141Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146429Automatic Regsitration2.72026-02-20
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145613Vascular Navigation PAD2.02025-09-11
04056481146672Mixed Reality Spine Navigation1.12025-07-31
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481146320Alignment Software Spine2.12025-06-16
04056481145828Microscope Navigation1.72025-06-11
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm564162025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mm564172025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm564182025-02-24
04056481146047Cirq Robotic Tracking Array 10.056302A2025-02-24
04056481146337Alignment Software Cranial with LITT2.12025-02-24
04056481145514Z-touch Laser Registration Pointer18370-10A2025-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
06974813830069NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830076NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830083NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830113NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830199NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830205NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16
07613327460742Navigation EnabledStryker CorporationOLO2019-10-16
07613327460759Navigation EnabledStryker CorporationOLO2019-10-16
07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
07613327460780Navigation EnabledStryker CorporationOLO2019-10-16