FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8034709150
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 47-0915
Device description
BENDING IRON 5 1/2" 3.5MM+2.7MM
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXWBender

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8034709150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B8034606210ORTHOMEDOM 46-06212026-07-14
B8034606250ORTHOMEDOM 46-06252026-07-14
B8034606370ORTHOMEDOM 46-063702026-07-14
B8034708900ORTHOMEDOM 47-08902026-07-14
B8034709160ORTHOMEDOM 47-09162026-07-14
B8034709170ORTHOMEDOM 47-09172026-07-14
B8034709180ORTHOMEDOM 47-09182026-07-14
B8034709190ORTHOMEDOM 47-09192026-07-14
B8034709290ORTHOMEDOM 47-09292026-07-14
B8034709510ORTHOMEDOM 47-09512026-07-14
B8034709530ORTHOMEDOM 47-09532026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034709160ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709170ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709180ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709190ORTHOMEDORTHO-MED, INC.HXW2026-07-14
008401944958133P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958203P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958373P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958443P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958513P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
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07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
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08809695630187GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809885726911Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885726928Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885798017Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
10887587077635NASynthes GmbHHXW2024-08-21
10887587077963NASynthes GmbHHXW2024-08-21
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G079C5040000020Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000030Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
08800089415212INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089417308INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089418268INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18