DEVICE: ZYSTON STRAIGHT SPACER SYSTEM (00888480504979)
Device Identifier (DI) Information
ZYSTON STRAIGHT SPACER SYSTEM
LV00717
In Commercial Distribution
LV00717
BIOMET SPINE LLC
LV00717
In Commercial Distribution
LV00717
BIOMET SPINE LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
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12696 | Orthopaedic inorganic implant inserter/extractor, reusable |
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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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Device Size Text, specify: MOD ZYSTON T-HANDLE INSERTER ZYSTON STRAIGHT SPACER SYSTEM |
Device Record Status
ec20bffd-03b9-422d-9c72-02ecf22cdadb
January 03, 2025
5
September 11, 2021
January 03, 2025
5
September 11, 2021
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(800)447-3625
USBROCustomerService@zimmerbiomet.com
USBROCustomerService@zimmerbiomet.com