Syntec OS Spinal Fixation System 853091

GUDID 04719873287833

Smooth Rodφ5.5 x L120mm

SYNTEC SCIENTIFIC CORPORATION

Bone-screw internal spinal fixation system rod
Primary Device ID04719873287833
NIH Device Record Key18a50177-c931-4ef6-a6b7-a8c31ba47c2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyntec OS Spinal Fixation System
Version Model Number853091
Catalog Number853091
Company DUNS657692971
Company NameSYNTEC SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873287833 [Primary]

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719873287833]

Moist Heat or Steam Sterilization


[04719873287833]

Moist Heat or Steam Sterilization


[04719873287833]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-13
Device Publish Date2026-02-05

On-Brand Devices [Syntec OS Spinal Fixation System]

04719873287833Smooth Rodφ5.5 x L120mm
04719873287796Smooth Rodφ5.5 x L100mm
04719873286607Polyaxial Long Arm Pedicle Screwφ5.0 x L40mm
04719873285167Set Screw H5.0mm
04719873284986Polyaxial Pedicle Screwφ6.5 x L45mm
04716873713751Cross-Link 50/70mm

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