DEVICE: Optimized Ortho Positioning (OPS) Femoral (09351327000039)
Device Identifier (DI) Information
Optimized Ortho Positioning (OPS) Femoral
1250-1100
In Commercial Distribution
OPTIMIZED ORTHO PTY LTD
1250-1100
In Commercial Distribution
OPTIMIZED ORTHO PTY LTD
Patient Specific Femoral Guide
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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60826 | Custom-made orthopaedic/craniofacial surgical guide |
A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PBF | Orthopaedic Surgical Planning And Instrument Guides |
LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
22086808-05b1-4e77-8692-bac7cff334f2
December 04, 2020
2
April 12, 2019
December 04, 2020
2
April 12, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined