DEVICE: NA (10886982237019)

Device Identifier (DI) Information

NA
498.837S
In Commercial Distribution
498837S
Synthes GmbH
10886982237019
GS1

1
486711679 *Terms of Use
3.5MM TI CERCLAGE POSITIONING PIN-STERILE
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JDQ CERCLAGE, FIXATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K992891 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

6d14f66d-ab0a-4de9-86f6-5f9736f5abad
January 06, 2025
6
September 14, 2015
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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
HIBCC H679498837S0
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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
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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