DEVICE: Pantheon System (08050880238217)

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Device Record History
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Device Identifier (DI) Information
Pantheon System
Bridging Collar
In Commercial Distribution
0201020
ADLER ORTHO SPA
08050880238217
GS1

1
338847291 *Terms of Use
Pantheon Bridging Collar Ø 26 mm for Stem Ø 12 mm
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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?
61560 Sleeve femoral/tibial extension, uncoated
A sterile implantable device typically designed to be attached to a revision femoral stem prosthesis, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to compensate for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.
Active true
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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
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter 26mm for Stem Diameter 12mm
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Device Record Status
a3ef2b1e-1e7a-4ba8-acde-d7be3dae8750
March 10, 2025
1
February 28, 2025
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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

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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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