FDA.reportPublic FDA data

Xspan Laminoplasty Fixation System

Primary DI
M697T08500251
Brand
Xspan Laminoplasty Fixation System
Company
Xtant Medical Holdings, Inc.
Model
T085-0025
Device description
Lamina Elevator
Published
2025-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTEElevator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T08500250Direct MarkingHIBCC0
M697T08500251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-886-9354CS@xtantmedical.com

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03
00840311244928Streamline MIS Spinal Fixation System04-55-PR-15004-55-PR-1502026-06-03
00840311244935Streamline MIS Spinal Fixation System04-55-PR-16004-55-PR-1602026-06-03
00840311244942Streamline MIS Spinal Fixation System04-55-PR-17004-55-PR-1702026-06-03
00840311245017Streamline MIS Spinal Fixation System04-55-PR-5504-55-PR-552026-06-03
00840311245024Streamline MIS Spinal Fixation System04-55-PR-6004-55-PR-602026-06-03
00840311245062Streamline MIS Spinal Fixation System04-55-PR-8004-55-PR-802026-06-03
00840311245079Streamline MIS Spinal Fixation System04-55-PR-9004-55-PR-902026-06-03
00840311245130Streamline MIS Spinal Fixation System04-55-RR-15004-55-RR-1502026-06-03
00840311245154Streamline MIS Spinal Fixation System04-55-RR-17004-55-RR-1702026-06-03
00840311245161Streamline MIS Spinal Fixation System04-55-RR-18004-55-RR-1802026-06-03
00840311245185Streamline MIS Spinal Fixation System04-55-RR-20004-55-RR-2002026-06-03
00840311245208Streamline MIS Spinal Fixation System04-55-RR-22004-55-RR-2202026-06-03
00840311245222Streamline MIS Spinal Fixation System04-55-RR-24004-55-RR-2402026-06-03
00840311245239Streamline MIS Spinal Fixation System04-55-RR-25004-55-RR-2502026-06-03
00840311245253Streamline MIS Spinal Fixation System04-55-RR-3504-55-RR-352026-06-03
00840311245284Streamline MIS Spinal Fixation System04-55-RR-4504-55-RR-452026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811078988INKAThe Trustee for KAISER FAMILY TRUSTHTE2026-03-18
10840199507723SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507730SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507747ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507754ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507761ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507778ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507785ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507792ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507808ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507815ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507877ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507969ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511447ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511454ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526540ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526557ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199545558ElevatorKOROS U.S.A., INC.HTE2024-02-05
10840199527288ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527295ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527301ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527318ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527325ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527332ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527349ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527356ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199528315ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529077Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529084Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529091Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31