Optimized Ortho Positioning (OPS) System

GUDID 09351327001302

OPS Reusable Instrument Inner Tray

OPTIMIZED ORTHO PTY LTD

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

Primary Device ID	09351327001302
NIH Device Record Key	01937c86-2ff0-4af6-9cea-e79c071f71b3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Optimized Ortho Positioning (OPS) System
Version Model Number	1248-5000
Company DUNS	745735175
Company Name	OPTIMIZED ORTHO PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351327001302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152893

FDA Product Code

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