FDA.reportPublic FDA data

n/a

Primary DI
00822409086832
Brand
n/a
Company
Ortho Development Corporation
Model
271-5002
Device description
Lateral, Alignment Guide 40degx15deg
Published
2020-08-19
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
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
00822409086832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409086832008224090868328224090868320822409086832

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
Angle15degree
Angle40degree

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
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
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
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181711Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181728Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181735Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26