DEVICE: DJO SURGICAL (00888912144001)
Device Identifier (DI) Information
DJO SURGICAL
506-06-000
In Commercial Distribution
Encore Medical, L.P.
506-06-000
In Commercial Distribution
Encore Medical, L.P.
ADAPTOR, HUMERAL STEM, RSP, SIZE6MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PHX | shoulder prosthesis, reverse configuration |
KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K052086 | 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
16093e26-2f02-4d9a-a29e-542c5d18f33d
October 18, 2018
4
August 07, 2017
October 18, 2018
4
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