Origin Short 125deg Trial Neck

Primary DI
09348215081423
Brand
Origin Short 125deg Trial Neck
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-182-027
Published
2021-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201951000Cemented Origin Hip StemSignature Orthopaedics Pty, Ltd.2020-07-31LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215081423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215081423093482150814239348215081423

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

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215010973Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Left10-1521-03022026-05-18
09348215010980Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Right10-1522-03222026-05-18
09348215010997Active-V Knee Cementless CR Femoral Component - Size 1 - Left10-1521-03032026-05-18
09348215011000Active-V Knee Cementless CR Femoral Component - Size 1 - Right10-1522-03232026-05-18
09348215011017Active-V Knee Cementless CRFemoral Component - Size 2 Narrow - Left10-1521-03042026-05-18
09348215011024Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right10-1522-03242026-05-18
09348215011031Active-V Knee Cementless CRFemoral Component - Size 2 - Left10-1521-03052026-05-18
09348215011048Active-V Knee Cementless CR Femoral Component - Size 2 - Right10-1522-03252026-05-18
09348215011055Active-V Knee Cementless CRFemoral Component - Size 3 Narrow - Left10-1521-03062026-05-18
09348215011062Active-V Knee Cementless CR Femoral Component - Size 3 Narrow - Right10-1522-03262026-05-18
09348215011079Active-V Knee Cementless CRFemoral Component - Size 3 - Left10-1521-03072026-05-18
09348215011086Active-V Knee Cementless CR Femoral Component - Size 3 - Right10-1522-03272026-05-18
09348215011093Active-V Knee Cementless CRFemoral Component - Size 4 Narrow - Left10-1521-03082026-05-18
09348215011109Active-V Knee Cementless CR Femoral Component - Size 4 Narrow - Right10-1522-03282026-05-18
09348215011116Active-V Knee Cementless CRFemoral Component - Size 4 - Left10-1521-03092026-05-18
09348215011123Active-V Knee Cementless CR Femoral Component - Size 4 - Right10-1522-03292026-05-18
09348215011130Active-V Knee Cementless CRFemoral Component - Size 5 Narrow - Left10-1521-02102026-05-18
09348215011147Active-V Knee Cementless CR Femoral Component - Size 5 Narrow - Right10-1522-02302026-05-18
09348215014506Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 Narrow10-1513-04002026-05-18
09348215014513Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 110-1513-04012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
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00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
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00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
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00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01