DEVICE: Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral (09351327000060)

Device Identifier (DI) Information

Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral
1248-1500, 1248-1700, 1250-1100,1250-1200
In Commercial Distribution

OPTIMIZED ORTHO PTY LTD
09351327000060
GS1

1
745735175 *Terms of Use
Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PBF Orthopaedic Surgical Planning And Instrument Guides
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152893 000
K181061 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5198be01-ffed-4618-9eef-1aeffb302fa8
December 04, 2020
2
April 18, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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