FDA.reportPublic FDA data

NextAR Spine Platform

Primary DI
07630345797070
Brand
NextAR Spine Platform
Company
Medacta International SA
Model
03.57.10.0184
Device description
Universal Camera Adapter medium size
Published
2023-07-24
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OLOOrthopedic Stereotaxic Instrument
PBFOrthopaedic Surgical Planning And Instrument Guides
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223769000NextAR™ Spine PlatformMedacta International S.A.2023-07-21SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345797070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345797070076303457970707630345797070

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971230156Spine Instruments03.30.10.20372026-05-12
07630971236745Spine Instruments03.30.10.20382026-05-12
07630971236752Spine Instruments03.30.10.20392026-05-12
07630971236769Spine Instruments03.30.10.20402026-05-12
07630971236776Spine Instruments03.30.10.20412026-05-12
07630971236783Spine Instruments03.30.10.20422026-05-12
07630971236790Spine Instruments03.30.10.20432026-05-12
07630971236806Spine Instruments03.30.10.20442026-05-12
07630971236813Spine Instruments03.30.10.20452026-05-12
07630971236820Spine Instruments03.30.10.20462026-05-12
07630542763748MectaLIF 3D Metal Anterior03.38.0012026-05-08
07630542763755MectaLIF 3D Metal Anterior03.38.0022026-05-08
07630542763762MectaLIF 3D Metal Anterior03.38.0032026-05-08
07630542763779MectaLIF 3D Metal Anterior03.38.0042026-05-08
07630542763786MectaLIF 3D Metal Anterior03.38.0052026-05-08
07630542763793MectaLIF 3D Metal Anterior03.38.0062026-05-08
07630542763809MectaLIF 3D Metal Anterior03.38.0072026-05-08
07630542763816MectaLIF 3D Metal Anterior03.38.0082026-05-08
07630542763823MectaLIF 3D Metal Anterior03.38.0092026-05-08
07630542763830MectaLIF 3D Metal Anterior03.38.0102026-05-08

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Primary DI, Brand, Company table
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07613327004175STRYKER NAV3IStryker Leibinger GmbH & Co. KGOLO2017-12-12
07613327004250ORTHOMAPStryker Leibinger GmbH & Co. KGOLO2017-12-12
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07613153100263NASTRYKER CORPORATIONOLO2016-09-23