Facet Fixation 58-0446

GUDID 10889981076610

Facet Screw 4.5MM x 46MM

SEASPINE ORTHOPEDICS CORPORATION

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID10889981076610
NIH Device Record Keyd98c3dda-05fd-480a-aabd-a2ec70a043f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFacet Fixation
Version Model Number58-0446
Catalog Number58-0446
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981076610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981076610]

Moist Heat or Steam Sterilization


[10889981076610]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-02-04

On-Brand Devices [Facet Fixation]

10889981143183Facet Lag Screw, 4.5mm x 54mm
10889981143176Facet Screw, 4.5mm x 54mm
10889981122836Facet Lag Screw 4.5MM x 58MM
10889981100674Washer Caddy
108899811006674.5mm Lag Screw Caddy
108899811006504.5mm Screw Caddy
10889981100643Facet Tray Lid
10889981100636Facet Tray Insert
10889981100629Facet Tray Base
10889981100612Facet Tray
10889981100605Dilator Handle
10889981100599Retrieval Tool
10889981100582Large Dilator
10889981100575Medium Dilator
10889981100568Small Dilator
10889981100551Drill Guide
108899811005445.0mm Cannulated Tap
108899811005374.5mm Cannulated Tap
10889981100520Access Needle Stylet
10889981100513Slim T Handle
10889981100506Ratcheting Pineapple Handle Push Forward
10889981100490Facet Access Needle
10889981100483Facet Universal Driver Shaft
10889981100476Facet Universal Driver Handle
10889981100469Washer Retaining Sheath
10889981100452Drill for DIA 5.0mm Facet Screw
10889981100445Drill for DIA 4.5mm Facet Screw
108899811004383.5mm Cannulated Driver
10889981100421Guidewire, 25 in
10889981077037Facet Lag Screw 4.5MM x 55MM
10889981077020Facet Lag Screw 4.5MM x 50MM
10889981077006Facet Lag Screw 4.5MM x 46MM
10889981076979Facet Lag Screw 4.5MM x 42MM
10889981076955Facet Lag Screw 4.5MM x 38MM
10889981076931Facet Lag Screw 4.5MM x 34MM
10889981076917Facet Lag Screw 4.5MM x 30MM
10889981076894Facet Lag Screw 4.5MM x 26MM
10889981076641Facet Screw 4.5MM x 55MM
10889981076634Facet Screw 4.5MM x 50MM
10889981076610Facet Screw 4.5MM x 46MM
10889981076597Facet Screw 4.5MM x 42MM
10889981076573Facet Screw 4.5MM x 38MM
10889981076559Facet Screw 4.5MM x 34MM
10889981076535Facet Screw 4.5MM x 30MM
10889981076511Facet Screw 4.5MM x 26MM
10889981076467Facet Washer

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.