FDA.reportPublic FDA data

Fixture Removal Trephine and Guide Sleeve Kit 19 mm

Primary DI
07340152101723
Brand
Fixture Removal Trephine and Guide Sleeve Kit 19 mm
Company
Integrum AB
Model
2542
Device description
The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture.The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.
Published
2023-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemoral AmputeesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190009003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190009003OPRA Implant SystemIntegrum AB2020-12-18PJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340152101723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340152101723073401521017237340152101723

GMDN Terms#

Term, Definition table
TermDefinition
Internal-external leg prosthesis osseointegration barA rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
356739813
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340152100313OPRA Implant System179517952016-11-17
07340152100337OPRA Implant System179717972016-11-17
07340152100344OPRA Implant System179817982016-11-17
07340152100351OPRA Implant System181618162015-12-18
07340152100368OPRA Implant System181718172016-11-17
07340152100375OPRA Implant System181818182016-03-04
07340152100382OPRA Implant System181918192016-03-04
07340152100160OPRA Implant System135313532016-03-30
07340152101709Fixture Removal Trephine and Guide Sleeve Kit 18 mm25402023-07-28
07340152101372OPRA Implant System14722017-08-08
07340152101389OPRA Implant System14732017-08-08
07340152100177OPRA Implant System180018002016-03-30
07340152100184OPRA Implant System180118012016-03-30
07340152100191OPRA Implant System180218022016-03-30
07340152100207OPRA Implant System180318032016-03-30
07340152100214OPRA Implant System180418042016-03-30
07340152100221OPRA Implant System180518052016-03-30
07340152100238OPRA Implant System180618062016-03-30
07340152100245OPRA Implant System180718072016-03-30
07340152100252OPRA Implant System180818082016-03-30

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Primary DI, Brand, Company table
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07340152102119OPRA™ Implant System Abutment 12x78 +1Integrum ABPJY2023-12-18
07340152102126OPRA™ Implant System Abutment 12x78 +2Integrum ABPJY2023-12-18
07340152102133OPRA™ Implant System Abutment 12x78 +3Integrum ABPJY2023-12-18
07340152102140OPRA™ Implant System Abutment 12x78 +4Integrum ABPJY2023-12-18
07340152102157OPRA™ Implant System Abutment 12x78 +5Integrum ABPJY2023-12-18
07340152102164OPRA™ Implant System Abutment 12x78 +6Integrum ABPJY2023-12-18
07340152102171OPRA™ Implant System Abutment 12x78 +7Integrum ABPJY2023-12-18
07340152102188OPRA™ Implant System Abutment 12x78 +8Integrum ABPJY2023-12-18
07340152102195OPRA™ Implant System Abutment 12x78 +9Integrum ABPJY2023-12-18
07340152102201OPRA™ Implant System Abutment 12x78 +10Integrum ABPJY2023-12-18
07340152102218OPRA™ Implant System Drill-bit 11,7 mmIntegrum ABPJY2023-12-18
07340152101679Fixture Removal Trephine and Guide Sleeve Kit 16,5 mmIntegrum ABPJY2023-07-28
07340152101686Fixture Removal Trephine and Guide Sleeve Kit 17 mmIntegrum ABPJY2023-07-28
07340152101693Fixture Removal Trephine and Guide Sleeve Kit 17,5 mmIntegrum ABPJY2023-07-28
07340152101709Fixture Removal Trephine and Guide Sleeve Kit 18 mmIntegrum ABPJY2023-07-28
07340152101716Fixture Removal Trephine and Guide Sleeve Kit 18,5 mmIntegrum ABPJY2023-07-28
07340152101730Fixture Removal Trephine and Guide Sleeve Kit 19,5 mmIntegrum ABPJY2023-07-28
07340152101747Fixture Removal Trephine and Guide Sleeve Kit 20 mmIntegrum ABPJY2023-07-28
07340152101754Fixture Removal Trephine and Guide Sleeve Kit 21 mmIntegrum ABPJY2023-07-28
07340152101761Fixture Removal Trephine and Guide Sleeve Kit 22 mmIntegrum ABPJY2023-07-28
07340152101778Fixture Removal Trephine and Guide Sleeve Kit 23 mmIntegrum ABPJY2023-07-28
07340152101785Fixture Removal Trephine and Guide Sleeve Kit 24 mmIntegrum ABPJY2023-07-28
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