DEVICE: 28mm x 11mm Oblique Trial Kit 8, 9, 10, 11 mm Heights (B064XM12889011)

Device Identifier (DI) Information

28mm x 11mm Oblique Trial Kit 8, 9, 10, 11 mm Heights
XM-128-8901
In Commercial Distribution

XENCO MEDICAL LLC
B064XM12889011
HIBCC

1
079282130 *Terms of Use
28mm x 11mm Oblique Trials 8, 9, 10, 11 mm Heights
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic implant/trial-implant holder, single-use A sterile hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

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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

50fdc03f-1dd2-4936-a096-d564f81b4cdf
May 08, 2018
3
October 28, 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
Yes
No
No CLOSE

Customer Contact

[?]
858-202-1505
sales@xencomedical.com
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