FDA.reportPublic FDA data

iNSitu™ Hip System

Primary DI
00810030811565
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-90-0000
Device description
Preoperative Template, Femoral Stems Assembly
Published
2023-08-28
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810030811565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810030811565008100308115658100308115650810030811565

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(330) 733-7600info@theken.us

Regulatory Flags#

DUNS number
060211165
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810030810575InSitu Hip System10-83-04572026-06-01
00810030810582InSitu Hip System10-83-04582026-06-01
00810030810599InSitu Hip System10-83-04592026-06-01
00810030810605InSitu Hip System10-83-04602026-06-01
00810030810612InSitu Hip System10-83-04612026-06-01
00810030810629InSitu Hip System10-83-04622026-06-01
00810030810636InSitu Hip System10-83-04632026-06-01
00810030810643InSitu Hip System10-83-04642026-06-01
00810030810650InSitu Hip System10-83-04652026-06-01
00810030810667InSitu Hip System10-83-04662026-06-01
00810030810674InSitu Hip System10-83-04672026-06-01
00810030810681InSitu Hip System10-83-04682026-06-01
00810030810698InSitu Hip System10-83-04692026-06-01
00810030810704InSitu Hip System10-83-04702026-06-01
00810030811657InSitu Hip System10-95-2081-452026-06-01
00810030811671InSitu Hip System10-95-2081-602026-06-01
00810030811992InSitu Hip System10-85-36482026-06-01
00810030812036InSitu Hip System10-84-20422026-06-01
00810030812043InSitu Hip System10-84-20442026-06-01
00810030812050InSitu Hip System10-84-20462026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200103096ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103102ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103119ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103126ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103133ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103140ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103157ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103164ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103522ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103539ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103546ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103553ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103560ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103577ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103584ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103591ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103607ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103614ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103782ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103799ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103805ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103812ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103829ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103836ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103843ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103850ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103867ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103935ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103942ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103959ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17