FDA.report

N/A

Primary DI
00822409116706
Brand
N/A
Company
Ortho Development Corporation
Model
613-4005
Device description
Neck Trial, STD, Size 10-12
Published
2024-04-01
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

Related Records

Contact Domains

Product Codes

CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications

CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822409116706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409116706008224091167068224091167060822409116706

GMDN Terms

TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags

DUNS number
876542390
Device count
1
DM exempt
false
Premarket exempt
false
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 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 DIBrandCompanyProduct codePublished
04048844732004implaFit®implantcast GmbHMEH2026-03-20
04048844732066implaFit®implantcast GmbHMEH2026-03-20
04048844781101implaFit®implantcast GmbHMEH2026-03-20
10885862660589N/AExactech, Inc.MEH2026-03-19
10885862660688N/AExactech, Inc.MEH2026-03-19
10885862660916NovationExactech, Inc.MEH2026-03-19
10885862660985N/AExactech, Inc.MEH2026-03-19
10885862660992N/AExactech, Inc.MEH2026-03-19
10885862661036N/AExactech, Inc.MEH2026-03-19
10885862661074N/AExactech, Inc.MEH2026-03-19
10885862661128N/AExactech, Inc.MEH2026-03-19
10885862661135N/AExactech, Inc.MEH2026-03-19
10885862661142N/AExactech, Inc.MEH2026-03-19
10885862661289N/AExactech, Inc.MEH2026-03-19
10885862661296N/AExactech, Inc.MEH2026-03-19
10885862661302NovationExactech, Inc.MEH2026-03-19
10885862661319NovationExactech, Inc.MEH2026-03-19
10885862661326NovationExactech, Inc.MEH2026-03-19
10885862661333NovationExactech, Inc.MEH2026-03-19
10885862661340NovationExactech, Inc.MEH2026-03-19
10885862661357NovationExactech, Inc.MEH2026-03-19
04048844693350implaFit®implantcast GmbHMEH2026-03-17
04048844693381implaFit®implantcast GmbHMEH2026-03-17
04048844693398implaFit®implantcast GmbHMEH2026-03-17
04048844693503implaFit®implantcast GmbHMEH2026-03-17
04048844693527implaFit®implantcast GmbHMEH2026-03-17
07630542790799Mfinity Femoral SystemMedacta International SAMEH2026-02-27
07630542790805Mfinity Femoral SystemMedacta International SAMEH2026-02-27
07630542790812Mfinity Femoral SystemMedacta International SAMEH2026-02-27
07630542790829Mfinity Femoral SystemMedacta International SAMEH2026-02-27