DEVICE: DJO SURGICAL (00888912144742)

Device Identifier (DI) Information

DJO SURGICAL
510-10-175
In Commercial Distribution

Encore Medical, L.P.
00888912144742
GS1

1
154074504 *Terms of Use
REVERSE® SHOULDER SYSTEM (RSP®) Revision Humeral Stem
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100741 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

cec49b75-41d3-438a-826b-fbfb287ad1a1
July 06, 2018
3
August 07, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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