FDA.reportPublic FDA data

Control unit

Primary DI
07640176970023
Brand
Control unit
Company
Naviswiss AG
Model
NS002
Device description
Control unit
Published
2024-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K193094000
K223351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193094000Naviswiss Hip Navigation SystemNaviswiss AG2020-06-10OLO
K223351000Naviswiss KneeNaviswiss AG2023-01-31OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640176970023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640176970023076401769700237640176970023

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation/tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures; it may be intended to overlay pre-acquired radiological images or real-time data [e.g., ultrasound (US)] for surgical navigation, and be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers 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., ENT, neurosurgery, CMF surgery].

Regulatory Flags#

DUNS number
483929829
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640176971327Sizer AdapterNS1322025-11-18
07640176970740Resection CheckerNS0742025-08-12
07640176970016Navigation unitNS0012024-05-16
07640176970108Set of NAVItags (sterile, single-use)NS0102024-05-16
07640176970115Tag adapter PNS0112024-05-16
07640176970122Tag adapter M (magnetic)NS0122024-05-16
07640176970153Hex screwdriver SW3.5mm (AO coupling)NS0152024-05-16
07640176970177Tag adapter FNS0172024-05-16
07640176970191Pelvic caliperNS0192024-05-16
07640176970214Speed pin (3.0 x 80 mm, wear part)NS0212024-05-16
07640176970221Speed pin adapterNS0222024-05-16
07640176970238Cortical bone screwNS0232024-05-16
07640176970252Calibration barNS0252024-05-16
07640176970306Sterilization tray (254 x 152 x 38 mm)NS0302024-05-16
07640176970320Tag adapter M (quick-lock)NS0322024-05-16
07640176970337PointerNS0332024-05-16
07640176970375Hex screwdriver SW3.5mm spherical headNS0372024-05-16
07640176970467Cortical bone screw (self drilling, 3.5 x 23 mm, wear part)NS0462024-05-16
07640176970481Single-pin tag mount (self-drilling, wear part)NS0482024-05-16
07640176970498Single-pin tag mount AO adapterNS0492024-05-16

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