DEVICE: DJO SURGICAL (00888912144087)
Device Identifier (DI) Information
DJO SURGICAL
507-08-175
In Commercial Distribution
Encore Medical, L.P.
507-08-175
In Commercial Distribution
Encore Medical, L.P.
STEM, HUMERAL, LONG, REVISION, RSP, SIZE8
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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33711 | Total reverse shoulder prosthesis |
A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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PHX | shoulder prosthesis, reverse configuration |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K041066 | 000 |
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
6c6de5ff-dad6-4f91-932e-cbd2a3828049
July 06, 2018
3
August 07, 2017
July 06, 2018
3
August 07, 2017
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