FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8034603180
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 46-0318
Device description
"LAMBOTTE OSTEOTOME 9"" STR. 1 1/4"""
Published
2022-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GFIOsteotome, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8034603180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B803904210SS0ORTHOMEDOM 90-4210-SSOM 90-4210-SS2026-05-08
B8037105136R0ORTHOMEDOM 71-0513-6ROM 71-0513-6R2026-05-01
B803KWIRE10C150S0ORTHOMEDKWIRE-10C-150SKWIRE-10C-150S2026-05-01
B8034802690ORTHOMEDOM 18-02692026-04-16
B8034803200ORTHOMEDOM 48-03202026-04-16
B8034803220ORTHOMEDOM 48-03222026-04-16
B8034803240ORTHOMEDOM 48-03242026-04-16
B8034803700ORTHOMEDOM 48-03702026-04-16
B8034803720ORTHOMEDOM 48-03722026-04-16
B8034803860ORTHOMEDOM 48-03862026-04-16
B8034803880ORTHOMEDOM 48-03882026-04-16
B8035202080ORTHOMEDOM 52-02082026-04-16
B8035202120ORTHOMEDOM 52-02122026-04-16
B8035202140ORTHOMEDOM 52-02142026-04-16
B8035202160ORTHOMEDOM 52-02162026-04-16
B8035202540ORTHOMEDOM 52-02542026-04-16
B8035202580ORTHOMEDOM 52-02582026-04-16
B8035202620ORTHOMEDOM 52-02622026-04-16
B8035202640ORTHOMEDOM 52-02642026-04-16
B8035202660ORTHOMEDOM 52-02662026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408574Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408581Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408727Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408734Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408741Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408758Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408765Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408772Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780188087Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188094Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188100Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188117Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188124Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188131Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188148Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188155Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188162Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188179Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188186Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188193Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188209Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188216Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188223Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188230Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188346Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188353Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02