FDA.reportPublic FDA data

Spider Cervical Plating System

Primary DI
M697N600019921
Brand
Spider Cervical Plating System
Company
Xtant Medical Holdings, Inc.
Model
N60001992
Device description
Spider System Temporary Fixation Pin, .70
Published
2015-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697N600019920Direct MarkingHIBCC0
M697N600019921PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.7Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Kit
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
06976712970334Hemo NeedleMicro-Energy Medical Technology Co., LtdGDF2026-07-13
04048223069738TunnEler 235Pajunk GmbH MedizintechnologieGDF2026-06-10
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199534132Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534149Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534156Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534163Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534170Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534187Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534194Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534231Needle HolderKOROS U.S.A., INC.GDF2022-08-01