FDA.reportPublic FDA data

GS1 Spinal System

Primary DI
M9935081200
Brand
GS1 Spinal System
Company
UNIFIED SPINE, LLC
Model
508120
Device description
Guide Wire, Nitinol
Published
2016-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9935081200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill guiding pinA sterile metal shaft (pin) designed to fit into the hollow centre of a cannulated surgical drill bit to provide a guide for drilling during a surgical procedure. The pin is bored into hard tissue (e.g., bone), typically by means of a surgical power tool handpiece, and the cannulated drill bit is subsequently fed over it during the drilling procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118413370
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
M9935042050GSO GS1 Spinal System5042052018-09-21
M9935042180GSO GS1 Spinal System5042182018-09-21
M9935042190GSO GS1 Spinal System5042192018-09-21
M9935071650GSO PCT Spinal System5071652018-09-21
M9935071760GSO PCT Spinal System5071762018-09-21
M9935071770GSO PCT Spinal System5071772018-09-21
M9935091200GSO ACP1 Anterior Cervical Plate System5091202016-09-14
M9935091220GSO ACP1 Anterior Cervical Plate System5091222016-09-14
M9935091240GSO ACP1 Anterior Cervical Plate System5091242016-09-14
M9935091260GSO ACP1 Anterior Cervical Plate System5091262016-09-14
M9935091280GSO ACP1 Anterior Cervical Plate System5091282016-09-14
M9935091300GSO ACP1 Anterior Cervical Plate System5091302016-09-15
M9935091320GSO ACP1 Anterior Cervical Plate System5091322016-09-14
M9935092340GSO ACP1 Anterior Cervical Plate System5092342016-09-15
M9935092370GSO ACP1 Anterior Cervical Plate System5092372016-09-15
M9935092400GSO ACP1 Anterior Cervical Plate System5092402016-09-15
M9935092430GSO ACP1 Anterior Cervical Plate System5092432016-09-15
M9935092460GSO ACP1 Anterior Cervical Plate System5092462016-09-15
M9935092490GSO ACP1 Anterior Cervical Plate System5092492016-09-15
M9935092520GSO ACP1 Anterior Cervical Plate System5092522016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
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