Optimized Ortho Positioning (OPS) System

GUDID 09351327000657

Laser Canister

OPTIMIZED ORTHO PTY LTD

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID09351327000657
NIH Device Record Key2245a5ad-5d54-47b9-a2ee-7a86bc56645d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimized Ortho Positioning (OPS) System
Version Model Number1248-0038
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109351327000657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09351327000657]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-19
Device Publish Date2020-02-11

On-Brand Devices [Optimized Ortho Positioning (OPS) System]

09351327000275Short Curved Guide Handle Screwdriver
09351327000268Short Curved Guide Handle Screw
09351327000251Long Curved Guide Handle
09351327000244Short Curved Guide Handle
09351327000237Reference Arm Long
09351327000220Reference Arm Short
09351327000213Right Angle Clamp
09351327000206Impactor Canister Adaptor 42.5mm
09351327000190Reamer Adaptor Stryker
09351327000183Canister Clamp
09351327000176Reference Post
09351327000169Laser Canister
09351327000152Laser Canister Cap
09351327000145Pelvic Screw Attachment
09351327000138Pelvic Screw Short
09351327000121Pelvic Screw Long
09351327000114T-Handle Introducer Assembly
09351327000107Impactor Canister Adaptor 39mm
09351327000015Trial Acetabulum
09351327000008Patient Specific Acetabular Guide
09351327000657Laser Canister
09351327000640Laser Canister Cap
09351327000633Pelvic Screw Attachment
09351327000626Pelvic Screw Short
09351327000619Pelvic Screw Long
09351327000602T-Handle Introducer
09351327000596Impactor Canister Adaptor 39mm
09351327001364OPS Reusable Instrument Outer Tray with Lid
09351327001302OPS Reusable Instrument Inner Tray

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