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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
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/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, commonly with respect to pre-acquired images and/or real-time data [e.g., computed tomography (CT), 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
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 Pinnacle100130-2272024-10-01
07350137520913OTS Hip Guide Reusable Set Emphasys100130-2282024-10-01
07350137520968Attachment Adapter Twin OT100630-1422024-10-01
07350137521002Threaded Pin Driver100460-0052024-10-01
07350137521026Calibration Adapter Unit OTD100330-1542024-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
07613327631814RPSStryker Leibinger GmbH & Co. KGOLO2025-10-03
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
04056481144906Spine &Trauma NavigationBrainlab SEOLO2024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMABrainlab SEOLO2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMPBrainlab SEOLO2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAYBrainlab SEOLO2024-11-14
04056481144753Drill Guide ArrayBrainlab SEOLO2024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)Brainlab SEOLO2024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)Brainlab SEOLO2024-06-04
04056481144784Drill Guide Tube (4.5 mm)Brainlab SEOLO2024-06-04
04056481144791Drill Guide Tube (3.2 mm)Brainlab SEOLO2024-06-04
04056481144807Drill Guide Tube (2.6 mm)Brainlab SEOLO2024-06-04
04056481144814Drill Guide Tube (2.4 mm)Brainlab SEOLO2024-06-04
04056481144821Drill Guide Tube (2.0 mm)Brainlab SEOLO2024-06-04
04056481144838Drill Guide HandleBrainlab SEOLO2024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)Brainlab SEOLO2024-06-04
04056481145064Drill Guide Trocar Insert (2.4 mm)Brainlab SEOLO2024-06-04
04056481145071Drill Guide Trocar Insert (2.6 mm)Brainlab SEOLO2024-06-04