FDA.reportPublic FDA data

OPRA Implant System

Primary DI
07340152100344
Brand
OPRA Implant System
Company
Integrum AB
Model
1798
Catalog number
1798
Device description
Healing Washer G 21x0.5
Published
2016-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJYTransfemoral Percutaneous Prosthetic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H080004000
P190009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H080004000
P190009000OPRA Implant SystemIntegrum AB2020-12-18PJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340152100344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340152100344073401521003447340152100344

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+46317601060info@integrum.se

Regulatory Flags#

DUNS number
356739813
Device count
1
Lot or batch
true
Expiration 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
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
07340152100269OPRA Implant System180918092016-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340152102379Instrument Kit: Hammer System F/ GIntegrum ABPJY2024-10-15
07340152102386Instrument Kit: Abutment Screw Adjustment GIntegrum ABPJY2024-10-15
07340152102065Instrument Kit Marrow Blood SampleIntegrum ABPJY2023-12-18
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
07340152101792Fixture Removal Trephine and Guide Sleeve Kit 25 mmIntegrum ABPJY2023-07-28
07340152102027Instrument Kit: Fractured Abutment/ Screw USAIntegrum ABPJY2023-07-25
07340152101662Fixture Removal Trephine and Guide Sleeve Kit 16 mmIntegrum ABPJY2023-07-15
07340152101723Fixture Removal Trephine and Guide Sleeve Kit 19 mmIntegrum ABPJY2023-07-15
07340152102225Fixture Removal Guide Pins Kit Platform GIntegrum ABPJY2023-07-15