FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8034606250
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 46-0625
Device description
WIRE CUT.7"FRONT+SIDE TC(MAX1.6MM)
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
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8034606250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted 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
B8034606370ORTHOMEDOM 46-063702026-07-14
B8034708900ORTHOMEDOM 47-08902026-07-14
B8034709150ORTHOMEDOM 47-09152026-07-14
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
B8034606210ORTHOMEDORTHO-MED, INC.HXZ2026-07-14
00810207784005Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784012Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784029Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
00192896122994Table Top Rod CutterSONTEC INSTRUMENTS, INC.HXZ2026-03-31
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
D90980001641ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D90980001651ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D9098000331SPECTRUMOrtho Arch Company IncHXZ2025-09-15
D90980021311RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021412RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021513RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021816RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15
00841435124912TecometTECOMET INC.HXZ2025-09-05
00190776409432MillenniumAvalign Technologies, Inc.HXZ2025-09-02
10818674026298Knotless flush cutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-12
10818674025994Multi Suture CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-11
00190776407766MillenniumAvalign Technologies, Inc.HXZ2025-08-01
00194613013912MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013929MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01