DEVICE: Screw System TX (E0HM79BTX009)

Device Identifier (DI) Information

Screw System TX
BTX00
In Commercial Distribution
BTX00
Hager & Meisinger Gesellschaft mit beschränkter Haftung
E0HM79BTX009
HIBCC

1
318034329 *Terms of Use
Screw system for fixation of bone segments e.g. for horizontal or vertical augmentative grafts The kit includes dental screws TX and neccessary accessories. The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. The following screws are included: 7pcs TCT09 007, 7pcs TCT09 010, 3pcs TCT10 007, 3pcs TCT10 010
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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, non-sterile A small, non-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). Screws available are: 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. This device must be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
DZL Screw, Fixation, Intraosseous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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

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Size Type Text
No Device Sizes
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Device Record Status

bb11130a-10dd-478f-85d6-3a9e9b4369dc
March 29, 2018
2
July 10, 2015
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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
No
No
No CLOSE

Customer Contact

[?]
+1 (303) 268-5400
info@meisingerusa.com
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