FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8034906520
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 49-0652
Device description
CHISEL BLADE 5MM STR. FOR OM49-630
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KDGChisel (Osteotome)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8034906520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chisel bladeA device that is an interchangeable component of an orthopaedic chisel and functions as the cutting blade which is attached and locked to a dedicated handle. Together, they become a single-blade surgical instrument, bevelled on one side, intended to cut or contour bone. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design and is typically made of high-grade stainless steel. 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
B8035202680ORTHOMEDOM 52-02682026-06-26
B803PS0099100A0ORTHOMEDOM PS00.991-00A2026-06-26
B803PS00991080ORTHOMEDOM PS00 991-082026-06-26
B803PS0099108A0ORTHOMEDOM PS00 991-08A2026-06-26
B803PS00991090ORTHOMEDOM PS00 991-092026-06-26
B803PS0099109A0ORTHOMEDOM PS00 991-09A2026-06-26
B803PS00991100ORTHOMEDOM PS00 991-102026-06-26
B803PS0099110A0ORTHOMEDOM PS00 991-10A2026-06-26
B803PS0395900ORTHOMEDOM PS03.959-02026-06-26
B803PS03959000ORTHOMEDOM PS03.959-002026-06-26
B803PS039590000ORTHOMEDOM PS03.959-0002026-06-26
B803PS0395910ORTHOMEDOM PS03.959-12026-06-26
B803PS0395920ORTHOMEDOM PS03.959-22026-06-26
B803PS0395930ORTHOMEDOM PS03.959-32026-06-26
B803PS0395950ORTHOMEDOM PS03.959-52026-06-26
B803PS0395960ORTHOMEDOM PS03.959-62026-06-26
B803PS0595940ORTHOMEDOM PS03.959-42026-06-26
B803NL97020450ORTHOMEDOM NL9702-0452026-06-25
B803PS00991010ORTHOMEDOM PS00 991-012026-06-25
B803PS0099101A0ORTHOMEDOM PS00 991-01A2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD918006150Surgical DirectSurgical Direct, Inc.KDG2026-07-13
B382SD918006200Surgical DirectSurgical Direct, Inc.KDG2026-07-13
B382SD921381110Surgical DirectSurgical Direct, Inc.KDG2026-02-12
B382SD9144841130Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841180Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841190Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD921613120Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201100Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201110Surgical DirectSurgical Direct, Inc.KDG2025-11-05
00198506086465ELMED INCORPORATEDELMED INCORPORATEDKDG2025-11-05
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622070Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622080Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622090Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622100Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622120Surgical DirectSurgical Direct, Inc.KDG2025-10-14
10840199528834Comfort Plus ChiselKOROS U.S.A., INC.KDG2025-01-31
10888277381339MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10888277392304MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10840199511423ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199511430ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199527394OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527400OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527417OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527424OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527431OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527448OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527455OsteotomeKOROS U.S.A., INC.KDG2024-12-31