DEVICE: Merete® CS Cortical Screw Fully Threaded (04048266154125)
Device Identifier (DI) Information
Merete® CS Cortical Screw Fully Threaded
3.5 26 T10
In Commercial Distribution
CR35326S
Merete GmbH
3.5 26 T10
In Commercial Distribution
CR35326S
Merete GmbH
TiAl6V4 ELI sterile
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 |
---|---|
Orthopaedic bone screw, non-bioabsorbable, sterile | A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | Plate, Fixation, Bone |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152187 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 26 Millimeter |
Outer Diameter: 3.5 Millimeter |
Device Record Status
2b9117b9-287b-4e83-b231-fe38c88b8a6b
August 01, 2018
4
April 22, 2016
August 01, 2018
4
April 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
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
[?]
630-613-7182
service@merete-medical.com
service@merete-medical.com