FDA.reportPublic FDA data

n/a

Primary DI
00822409086849
Brand
n/a
Company
Ortho Development Corporation
Model
271-5003
Device description
Lateral, Alignment Guide 45degx20deg
Published
2020-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409086849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409086849008224090868498224090868490822409086849

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic medialization instrumentA surgical instrument used to restore the anatomical and mechanical axes during orthopaedic correction osteotomies. It is typically designed as a robust block with a long, thin, adjusting rod running through its centre and an incremented measuring scale that enables the surgeon to gauge the adjustments made to the axes (the medialization). It is usually attached to a dedicated bone plate which is bridging the osteotomy site in order to achieve the correct offset of the two separated bone sections. It is typically made of high-grade stainless steel and can be used on adult and paediatric patients. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree
Angle45degree

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409130153N/A863-12062025-03-17
00822409130160N/A863-12072025-03-17
00822409130177N/A863-12082025-03-17
00822409130184N/A863-12092025-03-17
00822409130191N/A863-12102025-03-17
00822409130207N/A863-12112025-03-17
00822409130214N/A863-22062025-03-17
00822409130221N/A863-22072025-03-17
00822409130238N/A863-22082025-03-17
00822409130245N/A863-22092025-03-17
00822409130252N/A863-22102025-03-17
00822409130269N/A863-22112025-03-17
00822409082124N/A233-01382026-07-16
00822409082131N/A233-01392026-07-16
00822409082148N/A233-01402026-07-16
00822409082155N/A233-01412026-07-16
00822409082162N/A233-01422026-07-16
00822409082179N/A233-01432026-07-16
00822409082186N/A233-01442026-07-16
00822409082193N/A233-01452026-07-16

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Primary DI, Brand, Company table
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00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03