DEVICE: Pantheon PFR System (08050880237937)
Device Identifier (DI) Information
Pantheon PFR System
Salvage Plate with Spikes
In Commercial Distribution
0200715
ADLER ORTHO SPA
Salvage Plate with Spikes
In Commercial Distribution
0200715
ADLER ORTHO SPA
Pantheon Salvage Plate with Spikes L70mm
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? |
---|---|---|---|---|
46647 | Orthopaedic fixation plate, non-bioabsorbable |
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
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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Length: 70 Millimeter |
Device Record Status
cf10c5b1-ed6c-4464-8726-64650aded560
March 11, 2025
1
March 03, 2025
March 11, 2025
1
March 03, 2025
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
[?]
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