Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral

GUDID 09351327000053

Patient Specific Acetabular Guide, Trial Acetabulum and Patient Specific Femoral Guide

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 ID	09351327000053
NIH Device Record Key	6f57b947-c889-47ef-9b6f-35c17c3ef965
Commercial Distribution Status	In Commercial Distribution
Brand Name	Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral
Version Model Number	1248-1500, 1248-1700, 1250-1100
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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	09351327000053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152893

FDA Product Code

PBF	Orthopaedic Surgical Planning And Instrument Guides