DEVICE: STERILE TRAC SYSTEM (00841036162238)
Device Identifier (DI) Information
STERILE TRAC SYSTEM
SP-2976
Not in Commercial Distribution
SP-2976
BIOMET MICROFIXATION, INC
SP-2976
Not in Commercial Distribution
SP-2976
BIOMET MICROFIXATION, INC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
46638 | Craniofacial bone screw, non-bioabsorbable |
A small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.
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Active | true |
46642 | Craniofacial fixation plate, non-bioabsorbable, non-customized |
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | PLATE, FIXATION, BONE |
JEY | PLATE, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K972322 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
06d5219d-1639-4eee-8f51-2f12c3d77003
September 18, 2023
6
October 11, 2015
September 18, 2023
6
October 11, 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
[?]
+1(904)741-4400
FXJAX-ORDERS@ZIMMERBIOMET.COM
FXJAX-ORDERS@ZIMMERBIOMET.COM