FDA.reportPublic FDA data

Xspan Laminoplasty Fixation System

Primary DI
M697X0850306F06R1
Brand
Xspan Laminoplasty Fixation System
Company
Xtant Medical Holdings, Inc.
Model
X085-0306-F06-R
Device description
6mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
Published
2016-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQWOrthosis, Spine, Plate, Laminoplasty, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160114000Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.2016-03-15NQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X0850306F06R1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth6Millimeter
Length6Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM 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
03662663146524Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146531Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146548Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146555Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146562Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146579Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146586Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146593Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146609Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146616Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146623Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146234Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146241Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146258Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146265Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146272Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146289Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146296Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146302Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146319Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146326Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146333Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146340Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146357Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146364Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146371Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146388Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146395Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146401Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146418Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15