DEVICE: AXS, SmartLock (07613327385168)

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Device Record History
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Device Identifier (DI) Information
AXS, SmartLock
4727008E
In Commercial Distribution
4727008E
Stryker Leibinger GmbH & Co. KG
07613327385168
GS1

1
316153956 *Terms of Use
LOCKING SCREW,AXS,SELF-TAPPING
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Device Characteristics
MR Conditional
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?
34017 Sternal fixation device
A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HRS Plate, fixation, bone
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K183172 000
No CLOSE

Sterilization
No
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
Device Size Text, specify: Diameter: 2.7 Millimeter
Length: 8.0 Millimeter
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Device Record Status
e43bdc26-c866-496b-af8a-0273f4b0b137
April 24, 2019
1
April 16, 2019
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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
No Secondary DIs found
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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
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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