DEVICE: NA (10886982237019)
Device Identifier (DI) Information
NA
498.837S
In Commercial Distribution
498837S
Synthes GmbH
498.837S
In Commercial Distribution
498837S
Synthes GmbH
3.5MM TI CERCLAGE POSITIONING PIN-STERILE
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? |
---|---|---|---|---|
67083 | Orthopaedic fixation plate cerclage pin/eye |
A small implantable device designed to facilitate implantation of an orthopaedic fixation plate using cerclage cable or wire, whereby it attaches to the plate and/or underlying bone and provides a hole (eye) through which the cerclage cable is threaded. The pin portion may be one of a variety of designs which may be: 1) threaded into plate hole; 2) seated within a plate hole and inserted into the underlying bone; or 3) inserted into the drive hole of an appropriate screw head. It is used for plate fixation when screws are not an option. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JDQ | CERCLAGE, FIXATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K992891 | 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
6d14f66d-ab0a-4de9-86f6-5f9736f5abad
January 06, 2025
6
September 14, 2015
January 06, 2025
6
September 14, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | H679498837S0 |
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
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx