Shoreline ASC 86-0609

GUDID 10889981127565

18x15x9mm, 15 Degree Trial

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial
Primary Device ID10889981127565
NIH Device Record Key740061ad-01b6-4fc2-8d56-e63db5d58c77
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoreline ASC
Version Model Number86-0609
Catalog Number86-0609
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 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 Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981127565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981127565]

Moist Heat or Steam Sterilization


[10889981127565]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-09-30

On-Brand Devices [Shoreline ASC]

1088998114034212mm, Locking Cover, Backup
1088998114033511mm, Locking Cover, Backup
1088998114032810mm, Locking Cover, Backup
108899811403119mm, Locking Cover, Backup
108899811403048mm, Locking Cover, Backup
108899811402987mm, Locking Cover, Backup
108899811402816mm, Locking Cover, Backup
108899811402745mm, Locking Cover, Backup
10889981137496DTS Drill, 14mm
10889981137489DTS Drill, 12mm
10889981137472Inserter With Stop
108899811374654.0mm Fixed Angle Screw, Self Tapping, 20mm
108899811374584.0mm Variable Screw, Self Tapping, 20mm
108899811374413.5mm Fixed Angle Screw, Self-Drilling, 20mm
108899811374343.5mm Variable Screw, Self-Drilling, 20mm
108899811374273.5mm Fixed Angle Screw, Self-Tapping, 20mm
108899811374103.5mm Variable Screw, Self-Tapping, 20mm
1088998113621510° Ultra Low Profile Interbody Caddy
10889981135041Rasp Head
10889981135034Rasp
10889981132637Trial 14x13x12mm, 10 Deg Lordosis, w/ Depth Stop
10889981132620Trial 14x13x11mm, 10 Deg Lordosis, w/ Depth Stop
10889981132613Trial 14x13x10mm, 10 Deg Lordosis, w/ Depth Stop
10889981132606Trial 14x13x9mm, 10 Deg Lordosis, w/ Depth Stop
10889981132590Trial 14x13x8mm, 10 Deg Lordosis, w/ Depth Stop
10889981132583Trial 14x13x7mm, 10 Deg Lordosis, w/ Depth Stop
10889981132576Trial 14x13x6mm, 10 Deg Lordosis, w/ Depth Stop
10889981130428Trial 20x15x12mm, 10 Deg Lordosis, w/ Depth Stop
10889981130411Trial 20x15x11mm, 10 Deg Lordosis, w/ Depth Stop
10889981130404Trial 20x15x10mm, 10 Deg Lordosis, w/ Depth Stop
10889981130398Trial 20x15x9mm, 10 Deg Lordosis, w/ Depth Stop
10889981130381Trial 20x15x8mm, 10 Deg Lordosis, w/ Depth Stop
10889981130374Trial 20x15x7mm, 10 Deg Lordosis, w/ Depth Stop
10889981130367Trial 20x15x6mm, 10 Deg Lordosis, w/ Depth Stop
10889981130350Trial 18x15x12mm, 10 Deg Lordosis, w/ Depth Stop
10889981130343Trial 18x15x11mm, 10 Deg Lordosis, w/ Depth Stop
10889981130336Trial 18x15x10mm, 10 Deg Lordosis, w/ Depth Stop
10889981130329Trial 18x15x9mm, 10 Deg Lordosis, w/ Depth Stop
10889981130312Trial 18x15x8mm, 10 Deg Lordosis, w/ Depth Stop
10889981130305Trial 18x15x7mm, 10 Deg Lordosis, w/ Depth Stop
10889981130299Trial 18x15x6mm, 10 Deg Lordosis, w/ Depth Sto
10889981130282Trial 16x14x12mm, 10 Deg Lordosis, w/ Depth Stop
10889981130275Trial 16x14x11mm, 10 Deg Lordosis, w/ Depth Stop
10889981130268Trial 16x14x10mm, 10 Deg Lordosis, w/ Depth Stop
10889981130251Trial 16x14x9mm, 10 Deg Lordosis, w/ Depth Stop
10889981130244Trial 16x14x8mm, 10 Deg Lordosis, w/ Depth Stop
10889981130237Trial 16x14x7mm, 10 Deg Lordosis, w/ Depth Stop
10889981130220Trial 16x14x6mm, 10 Deg Lordosis, w/ Depth Stop
1088998113021320x15x6mm, 10 Degree, Interbody
1088998113020618x15x6mm, 10 Degree, Interbody

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