Shoreline ACS 86-0013

GUDID 10889981164546

Inserter, Spacer

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable
Primary Device ID10889981164546
NIH Device Record Key3aeb4872-93f8-4050-a505-c0a1121e3dc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoreline ACS
Version Model Number86-0013
Catalog Number86-0013
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981164546 [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

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-01
Device Publish Date2022-05-24

On-Brand Devices [Shoreline ACS]

10889981162573Tap, 20mm
10889981162566Tap, 18mm
10889981162559Tap, 10mm
10889981162542Drill, 20mm
10889981162535Drill, 18mm
10889981162528Drill, 10mm
10889981161996Tray, Trials and Rasp Tray
10889981161989Tray, Screw Prep and Final Tightening
10889981161972Tray, Plates, Screws, and Locking Covers
10889981161965Case Lid
10889981161958Case, Shoreline Instrument and Fixation Tray
10889981149635Shoreline Hyperlordotic Modular Trial Tray
10889981149499Plate Assembly Tool
10889981149277Plate Template
10889981146382Angled DTS Awl
10889981146375Angled DTS Driver
1088998114498215° Modular Trial Caddy
1088998114497510° Modular Trial Caddy
10889981144968Shoreline Hyperlordotic Instrument Tray
10889981144852Modular Trial 20x15x12mm, 15 Deg Lordosis, w/ Depth Stop
10889981144845Modular Trial 20x15x11mm, 15 Deg Lordosis, w/ Depth Stop
10889981144838Modular Trial 20x15x10mm, 15 Deg Lordosis, w/ Depth Stop
10889981144821Modular Trial 20x15x9mm, 15 Deg Lordosis, w/ Depth Stop
10889981144814Modular Trial 20x15x8mm, 15 Deg Lordosis, w/ Depth Stop
10889981144807Modular Trial 18x15x12mm, 15 Deg Lordosis, w/ Depth Stop
10889981144791Modular Trial 18x15x11mm, 15 Deg Lordosis, w/ Depth Stop
10889981144784Modular Trial 18x15x10mm, 15 Deg Lordosis, w/ Depth Stop
10889981144777Modular Trial 18x15x9mm, 15 Deg Lordosis, w/ Depth Stop
10889981144760Modular Trial 18x15x8mm, 15 Deg Lordosis, w/ Depth Stop
10889981144753Modular Trial 16x14x12mm, 15 Deg Lordosis, w/ Depth Stop
10889981144746Modular Trial 16x14x11mm, 15 Deg Lordosis, w/ Depth Stop
10889981144739Modular Trial 16x14x10mm, 15 Deg Lordosis, w/ Depth Stop
10889981144722Modular Trial 16x14x9mm, 15 Deg Lordosis, w/ Depth Stop
10889981144715Modular Trial 16x14x8mm, 15 Deg Lordosis, w/ Depth Stop
10889981144708Modular Trial 16x14x7mm, 15 Deg Lordosis, w/ Depth Stop
10889981144692Modular Trial 20x15x12mm, 10 Deg Lordosis, w/ Depth Stop
10889981144685Modular Trial 20x15x11mm, 10 Deg Lordosis, w/ Depth Stop
10889981144678Modular Trial 20x15x10mm, 10 Deg Lordosis, w/ Depth Stop
10889981144661Modular Trial 20x15x9mm, 10 Deg Lordosis, w/ Depth Stop
10889981144654Modular Trial 20x15x8mm, 10 Deg Lordosis, w/ Depth Stop
10889981144647Modular Trial 20x15x7mm, 10 Deg Lordosis, w/ Depth Stop
10889981144630Modular Trial 20x15x6mm, 10 Deg Lordosis, w/ Depth Stop
10889981144623Modular Trial 18x15x12mm, 10 Deg Lordosis, w/ Depth Stop
10889981144616Modular Trial 18x15x11mm, 10 Deg Lordosis, w/ Depth Stop
10889981144609Modular Trial 18x15x10mm, 10 Deg Lordosis, w/ Depth Stop
10889981144593Modular Trial 18x15x9mm, 10 Deg Lordosis, w/ Depth Stop
10889981144586Modular Trial 18x15x8mm, 10 Deg Lordosis, w/ Depth Stop
10889981144579Modular Trial 18x15x7mm, 10 Deg Lordosis, w/ Depth Stop
10889981144562Modular Trial 18x15x6mm, 10 Deg Lordosis, w/ Depth Stop
10889981144555Modular Trial 16x14x12mm, 10 Deg Lordosis, w/ Depth Stop
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