FDA.reportPublic FDA data

OSCAR 3

Primary DI
18056099649964
Brand
OSCAR 3
Company
ORTHOFIX SRL
Model
1
Catalog number
OHRE2001SU
Device description
LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBES
Published
2017-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDXInstrument, Surgical, Sonic And Accessory/Attachment
LZVSystem, Cement Removal Extraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2
LZVSystem, Cement Removal ExtractionOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093805000OSCAR 3Orthosonics, Ltd.2010-02-19JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056099649964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805609964996418056099649964

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
438793622
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
18053504361176TRUELOK SYSTEM154-115602018-04-28
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18059015376661MINIRAL1M191-022026-05-04
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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

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