FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8032905840
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 29-0584
Device description
"SCHAMBERG COMDNE EXTR 3 3/4"" SQUARE"
Published
2022-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8032905840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument extractorA hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. 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
B8034609130ORTHOMEDOM 46-09132026-07-16
B8034609140ORTHOMEDOM 46-09142026-07-16
B8034609150ORTHOMEDOM 46-09152026-07-16
B8034609160ORTHOMEDOM 46-09162026-07-16
B8034803030ORTHOMEDOM 48-03032026-07-16
B8034803360ORTHOMEDOM 48-03362026-07-16
B8034803370ORTHOMEDOM 48-03372026-07-16
B8034803380ORTHOMEDOM 48-03382026-07-16
B8034803390ORTHOMEDOM 48-03392026-07-16
B8034803400ORTHOMEDOM 48-03402026-07-16
B8034803410ORTHOMEDOM 48-03412026-07-16
B8034500040ORTHOMEDOM 45-00042026-07-14
B8034503260ORTHOMEDOM 45-03262026-07-14
B8034503660ORTHOMEDOM 45-03662026-07-14
B8034503700ORTHOMEDOM 45-03702026-07-14
B8034605720ORTHOMEDOM 46-05722026-07-14
B8034605730ORTHOMEDOM 46-05732026-07-14
B8034605740ORTHOMEDOM 46-05742026-07-14
B8034606180ORTHOMEDOM 46-06182026-07-14
B8034606190ORTHOMEDOM 46-06192026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10
00841435120365TecometTECOMET INC.HWB2022-10-03
00841435111226TecometTECOMET INC.HWB2020-10-09
00818069014858TecometTECOMET INC.HWB2020-10-09
00841435100688TecometTECOMET INC.HWB2020-10-09
00841435100695TecometTECOMET INC.HWB2020-10-09
00818069014339TecometTECOMET INC.HWB2020-08-20
00818069014346TecometTECOMET INC.HWB2020-08-20
00818069014353TecometTECOMET INC.HWB2020-08-20
00818069014360TecometTECOMET INC.HWB2020-08-07
00818069014377TecometTECOMET INC.HWB2020-08-07
00818069014384TecometTECOMET INC.HWB2020-08-07
00818069014391TecometTECOMET INC.HWB2020-08-07
00818069014407TecometTECOMET INC.HWB2020-08-07
00818069014414TecometTECOMET INC.HWB2020-08-07
00863176000324FIBULINKSynthes GmbHHWB2020-03-26
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16