FDA.reportPublic FDA data

OSCAR PRO

Primary DI
18053340341813
Brand
OSCAR PRO
Company
ORTHOFIX SRL
Model
1
Catalog number
99-O4SCL08B04
Device description
OSCAR PRO TITANIUM CURVED BLADE SERRATED L80MM W4MM STERILE
Published
2021-03-18
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
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18053340341813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805334034181318053340341813

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Millimeter
Width4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18053504361176TRUELOK SYSTEM154-115602018-04-28
18059015376654MINIRAL1M191-012026-05-04
18059015376661MINIRAL1M191-022026-05-04
18059015376678MINIRAL1M1912026-05-04
18059015376692PENNIG MINIFIXATOR1M444-012026-05-04
18059015376708PENNIG MINIFIXATOR1M444-022026-05-04
18059015376715PENNIG MINIFIXATOR1M4442026-05-04
18059015376784PENNIG DYNAMIC WRIST FIXATOR113761-012026-05-04
18059015376791PENNIG DYNAMIC WRIST FIXATOR113761-022026-05-04
18059015376807PENNIG DYNAMIC WRIST FIXATOR113761-032026-05-04
18059015376814PENNIG DYNAMIC WRIST FIXATOR1137612026-05-04
18054242515173Galaxy UNYCO System199-936732016-07-27
18054242515180Galaxy UNYCO System199-936702016-07-27
18052469476055ORTHOFIX MODULSYSTEM1M1462022-12-27
18052469476086ORTHOFIX MODULSYSTEM199-M1462022-12-27
18052469476406ORTHOFIX MODULSYSTEM199-M14602022-12-27
18053504369721ORTHOFIX GALAXY FIXATION SYSTEM1930402019-05-31
18053504369738ORTHOFIX GALAXY FIXATION SYSTEM1931402019-05-31
18059015375879TrueLok Elevate150-2590C2025-01-03
18059015375909TrueLok Elevate150-25052025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972603519682SMTPSMTP Medical Co., Ltd.JDX2026-06-08
E322036000220MECTRONMECTRON SPAJDX2026-04-20
E322036300090MECTRONMECTRON SPAJDX2026-04-20
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030211Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHJDX2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHJDX2025-07-08