FDA.reportPublic FDA data

N/A

Primary DI
00822409099726
Brand
N/A
Company
Ortho Development Corporation
Model
852-0019B
Device description
French Rod Bender
Published
2023-10-06
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

Contact Domains#

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
00822409099726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409099726008224090997268224090997260822409099726

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
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
true
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
00822409131662N/AC-1838-072026-02-05
00822409131679N/AC-1838-082026-02-05
00822409131686N/AC-1838-092026-02-05
00822409131693N/AC-1838-102026-02-05
00822409131709N/AC-1838-112026-02-05
00822409131716N/AC-1838-122026-02-05
00822409131723N/AC-1838-132026-02-05
00822409131730N/AC-1838-142026-02-05
00822409131747N/AC-1838-162026-02-05
00822409131754N/AC-1838-182026-02-05
00822409131761N/AC-1838-202026-02-05
00822409131778N/AC-1839-072026-02-05
00822409131785N/AC-1839-082026-02-05
00822409131792N/AC-1839-092026-02-05
00822409131808N/AC-1839-102026-02-05
00822409131815N/AC-1839-112026-02-05
00822409131822N/AC-1839-122026-02-05
00822409131839N/AC-1839-132026-02-05
00822409131846N/AC-1839-142026-02-05
00822409131853N/AC-1839-162026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118144928LEVEL ONE EXTREMITYKLS-Martin L.P.HXW2026-05-25
03662663108386Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXW2026-02-11
00840536800237Response Spine SystemORTHOPEDIATRICS CORP.HXW2026-01-15
00840180543283General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
00840180543290General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
10889981095987GeneralSeaspine Orthopedics CorporationHXW2025-12-19
03662663261869BacFix Ti Spinal Fixation SystemHighridge Medical, LLCHXW2025-12-18
00840194418140PediflexORTHOPEDIATRICS CORP.HXW2025-12-11
00840493413907RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413914RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413921RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413938RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413945RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00199150044375Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
00199150044382Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
03662663153379Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153386Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153393Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153409Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663191784Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214872Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214889Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214896Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663146227Gallery Laminoplasty Fixation SystemHighridge Medical, LLCHXW2025-11-15
03662663113410Virage OCT Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663131995Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663132008Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663136785Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136792Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136808Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14