DEVICE: ALEUTIAN® Interbody Systems (10888857074590)
Device Identifier (DI) Information
ALEUTIAN® Interbody Systems
3303-21528W
In Commercial Distribution
3303-21528W
K2M, INC.
3303-21528W
In Commercial Distribution
3303-21528W
K2M, INC.
TLIF II Implant, Size 12x28x15 mm, 7 Deg.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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34170 | Vertebral body prosthesis |
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ODP | Intervertebral fusion device with bone graft, cervical |
MAX | Intervertebral fusion device with bone graft, lumbar |
MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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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Height: 15 Millimeter |
Length: 28 Millimeter |
Width: 12 Millimeter |
Angle: 7 degree |
Device Record Status
1f1e5459-0734-457e-9e7b-52c6b18b8802
July 31, 2023
4
May 19, 2017
July 31, 2023
4
May 19, 2017
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(571)919-2000
mark.zellers@stryker.com
mark.zellers@stryker.com