FDA.reportPublic FDA data

Xspan Laminoplasty Fixation System

Primary DI
M697T08500191
Brand
Xspan Laminoplasty Fixation System
Company
Xtant Medical Holdings, Inc.
Model
T085-0019
Device description
PLATE CUTTER, 9INCH
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
HTZInstrument, Cutting, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T08500190Direct MarkingHIBCC0
M697T08500191PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M697X07901151Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.HTZ2026-07-08
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
00196449033454Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033461Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033591Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033676Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034185Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034192Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034208Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034673Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034680Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034697Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
B471293000100GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000150GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000200GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000250GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
10886982339492NASynthes GmbHHTZ2024-10-09
10887587077611NASynthes GmbHHTZ2024-08-21
07898506814107QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814114QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841677QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841691QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841707QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841714QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841752QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506848959QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849413QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849420QuinelatoSchobell Industrial LtdaHTZ2023-01-10