Home GUDID M697T08500161 Xspan Laminoplasty Fixation System
Primary DI M697T08500161
Brand Xspan Laminoplasty Fixation System
Company Xtant Medical Holdings, Inc.
Model T085-0016
Device description LAMINA ELEVATOR
Published 2016-06-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HTE ELEVATOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTE Elevator General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697T08500160 Direct Marking HIBCC 0 M697T08500161 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10705034579580 N/A Medos International Sàrl HTE 2026-06-25 10705034579597 N/A Medos International Sàrl HTE 2026-06-25 10705034579603 N/A Medos International Sàrl HTE 2026-06-25 B8039702640 ORTHOMED ORTHO-MED, INC. HTE 2026-06-22 09348811078988 INKA The Trustee for KAISER FAMILY TRUST HTE 2026-03-18 10840199507723 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507730 Separator KOROS U.S.A., INC. HTE 2024-12-31 10840199507747 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507754 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507761 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507778 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507785 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507792 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507808 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507815 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507877 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199507969 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511447 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199511454 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526540 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199526557 Elevator KOROS U.S.A., INC. HTE 2024-12-31 10840199545558 Elevator KOROS U.S.A., INC. HTE 2024-02-05 10840199527288 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527295 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527301 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527318 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527325 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527332 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527349 Elevator KOROS U.S.A., INC. HTE 2024-01-31 10840199527356 Elevator KOROS U.S.A., INC. HTE 2024-01-31
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