Spinous Process System 95-3002

GUDID 10889981096175

Ligament Splitter

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implantable-device cutter
Primary Device ID10889981096175
NIH Device Record Keyd521b9a6-65f9-422a-9d6e-0c5b7778415f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinous Process System
Version Model Number95-3002
Catalog Number95-3002
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS110889981096175 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981096175]

Moist Heat or Steam Sterilization


[10889981096175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-21
Device Publish Date2018-04-18

On-Brand Devices [Spinous Process System]

10889981129705Plate Inserter, Spinous Process Spacer
10889981129613Spinous Process Implants and Instruments
10889981120603Spinous Process Tray, Caddy
1088998109628116mm Trial, Spinous Process Spacer
1088998109627414mm Trial, Spinous Process Spacer
1088998109626712mm Trial, Spinous Process Spacer
1088998109625010mm Trial, Spinous Process Spacer
108899810962438mm Trial, Spinous Process Spacer
108899810962366mm Trial, Spinous Process Spacer
10889981096205Compressor, Spinous Process Spacer
10889981096199Inserter, Spinous Process Spacer
10889981096175Ligament Splitter
10889981096151T15 Driver
10889981076238Spinous Process Spacer, 16mm
10889981076221Spinous Process Spacer, 14mm
10889981076214Spinous Process Spacer, 12mm
10889981076207Spinous Process Spacer, 10mm
10889981076191Spinous Process Spacer, 8mm
10889981076184Spinous Process Spacer, 6mm

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