FDA.reportPublic FDA data

Calibration Adapter Unit OTD Emphasys

Primary DI
07350137521033
Brand
Calibration Adapter Unit OTD Emphasys
Company
Ortoma AB (Publ)
Model
1002
Catalog number
30-204
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K232140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232140000OTS HipOrtoma AB2024-03-11OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350137521033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350137521033073501375210337350137521033

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and 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, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
633151436
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350137520593Inserter Adapter OTD Pinnacle Straight100130-2022024-10-03
07350137520647Measurement Screw 15 mm100160-0012024-10-03
07350137520654Measurement Screw 8 mm100160-0022024-10-03
07350137520661Threaded Pin 4x150 mm100160-0032024-10-03
07350137521019Inserter Adapter OTD Straight100230-2012024-10-03
07350137520005OTS Hip Plan520-1012024-10-01
07350137520029OTS Hip Guide SW520-1002024-10-01
07350137520036Stylet and Pin100330-1172024-10-01
07350137520043Pointer Holder100230-1502024-10-01
07350137520067Pointer OT100230-1552024-10-01
07350137520074Attachment Adapter Fix OT100230-1562024-10-01
07350137520081Reamer Adapter OTD100330-1572024-10-01
07350137520098Inserter Adapter OTD100430-1582024-10-01
07350137520678Measurement Screw Driver100260-0042024-10-01
07350137520692OTS Hip Solution Pinnacle100110-1022024-10-01
07350137520708OTS Hip Solution Emphasys100110-1032024-10-01
07350137520906OTS Hip Guide Reusable Set Pinnacle 100130-2272024-10-01
07350137520913OTS Hip Guide Reusable Set Emphasys100130-2282024-10-01
07350137520968Attachment Adapter Twin OT100630-1422024-10-01
07350137521002Threaded Pin Driver100460-0052024-10-01

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