DEVICE: DELTA (04546540337474)
Device Identifier (DI) Information
DELTA
70-22006
In Commercial Distribution
70-22006
Stryker Leibinger GmbH & Co. KG
70-22006
In Commercial Distribution
70-22006
Stryker Leibinger GmbH & Co. KG
DELTA 2.2X6MM SCREW, 1 EA
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 |
---|---|
Craniofacial bone screw, bioabsorbable | A small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K993061 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 49 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Diameter: 2.2 Millimeter |
Length: 6.0 Millimeter |
Device Record Status
db288408-0353-4010-8d57-1d4f5b9517fd
July 06, 2018
3
September 24, 2015
July 06, 2018
3
September 24, 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 |
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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
[?]
No Customer Contact currently defined