FDA.report

OTS Hip Plan

Primary DI
07350137520005
Brand
OTS Hip Plan
Company
Ortoma AB (Publ)
Model
5
Catalog number
20-101
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K232140000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232140000OTS HipOrtoma AB2024-03-11OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07350137520005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07350137520005073501375200057350137520005

GMDN Terms

TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods

Method

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
false
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
false

Other Devices From This Company

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 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
07350137521026Calibration Adapter Unit OTD100330-1542024-10-01

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