Optimized Positioning System (OPS) Femoral

GUDID 09351327000084

Patient Specific Femoral Guide+Trial Femoral Head

OPTIMIZED ORTHO PTY LTD

Custom-made orthopaedic surgical guide, non-sterile Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide
Primary Device ID09351327000084
NIH Device Record Key84651b88-796d-48c0-80a2-dd1c1cf614bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimized Positioning System (OPS) Femoral
Version Model Number1250-1100,1250-1200
Company DUNS745735175
Company NameOPTIMIZED ORTHO PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109351327000084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


[09351327000084]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-26
Device Publish Date2019-04-18

Devices Manufactured by OPTIMIZED ORTHO PTY LTD

09351327001302 - Optimized Ortho Positioning (OPS) System2022-06-03 OPS Reusable Instrument Inner Tray
09351327001364 - Optimized Ortho Positioning (OPS) System2022-06-03 OPS Reusable Instrument Outer Tray with Lid
09351327000848 - OPSInsight™2021-03-24 OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection,
09351327000695 - OPS2020-02-25 Impactor Canister Adaptor 42.5mm
09351327000701 - OPS2020-02-25 Right Angle Clamp
09351327000718 - OPS2020-02-25 Reference Arm Short
09351327000725 - OPS2020-02-25 Reference Arm Long
09351327000732 - OPS2020-02-25 Short Curved Guide Handle

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