DEVICE: MC-Subtalar™ II (04048266163011)

Device Identifier (DI) Information

MC-Subtalar™ II
10 30 T20
In Commercial Distribution
FH39301S
Merete GmbH
04048266163011
GS1

1
313267265 *Terms of Use
MC-Subtalar™ II Screw 10 30 T20 stainless steel
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Subtalar implant, non-bioabsorbable, sterile A sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).
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FDA Product Code

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Product Code Product Code Name
HWC Screw, Fixation, Bone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160548 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
Length: 30 Millimeter
Outer Diameter: 10 Millimeter
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Device Record Status

fcd55fbe-17e0-4361-8829-840b14f258a2
August 01, 2018
4
June 10, 2016
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
630-613-7182
service@merete-medical.com
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