Daytona Small Stature 76-0146

GUDID 10889981152499

Offset Hook, 4.0 x 6.5mm, Right

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10889981152499
NIH Device Record Key438031b0-984c-49d1-b63f-a310b91af1e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDaytona Small Stature
Version Model Number76-0146
Catalog Number76-0146
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
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981152499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

[10889981152499]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-24
Device Publish Date2018-06-23

On-Brand Devices [Daytona Small Stature]

10889985163101Sm Stat Hooks, Conn Tray, Axial Conn Caddy
10889985163095Axial Hook Inserter Sleeve
10889981161293Connector Set Screw, Replacement
10889981156770Laminar Hook, 12.0 x 8.0mm
10889981156763Laminar Hook, 12.0 x 6.5mm
10889981156756Laminar Hook, 12.0 x 12.0mm
10889981156749Laminar Hook, 12.0 x 10.0mm
10889981156732Laminar Hook, 10.0 x 8.0mm
10889981156725Laminar Hook, 10.0 x 6.5mm
10889981156718Laminar Hook, 10.0 x 5.5mm
10889981156701Laminar Hook, 10.0 x 10.0mm
10889981155346Laminar Hook, 5.25 x 8.0mm
10889981155339Laminar Hook, 5.25 x 6.5mm
10889981155322Laminar Hook, 5.25 x 5.5mm
10889981155315Laminar Hook, 5.25 x 4.25mm
10889981155308Laminar Hook, 8.0 x 8.0mm
10889981155292Laminar Hook, 8.0 x 6.5mm
10889981155285Laminar Hook, 8.0 x 5.5mm
10889981155278Laminar Hook, 8.0 x 4.25mm
10889981155261Offset Hook, 4.0 x 8.0mm, Right
10889981155254Offset Hook, 4.0 x 8.0mm, Left
10889981155247Angled Hook, 4.0 x 8.0mm, Right
10889981155230Angled Hook, 4.0 x 8.0mm, Left
10889981153199Sm Stat Hooks, Conn Tray, CrossBar Caddy
10889981153182Sm Stat Hooks, Conn Tray, Ext Axial Conn Caddy
10889981153168Sm Stat Hooks, Conn Tray, Level 2
10889981153151Sm Stat Hooks, Conn Tray, Add Hook Caddy
10889981153144Sm Stat Hooks, Conn Tray, Asst Hook Caddy
10889981153137Sm Stat Hooks, Conn Tray, Lam Hook Caddy
10889981153120Sm Stat Hooks, Conn Tray, Level 1
10889981153113Sm Stat Hooks, Conn Tray, Base
108899811531064mm Driver, Tri-Flat, Small Stature
10889981153090Tap 8.0mm, Tri-Flat, Cannulated (for 8.5mm Screw)
10889981153083Tap 7.5mm, Tri-Flat, Cannulated (for 8.0mm Screw)
10889981153076Tap 7.0mm, Tri-Flat, Cannulated (for 7.5mm Screw)
10889981153069Tap 6.5mm, Tri-Flat, Cannulated (for 7.0mm Screw)
10889981153052Tap 6.0mm, Tri-Flat, Cannulated (for 6.5mm Screw)
10889981153045Tap 5.5mm, Tri-Flat, Cannulated (for 6.0mm Screw)
10889981153038Tap 5.0mm, Tri-Flat, Cannulated (for 5.5mm Screw)
10889981153021Tap 4.5mm, Tri-Flat, Cannulated (for 5.0mm Screw)
10889981153014Tap 4.0mm, Tri-Flat, Cannulated (for 4.5mm Screw)
10889981153007Locking Driver Shaft, Tri-Flat, Small Stature
10889981152987Fixed CrossBar Sizing Tool, Small Stature
10889981152970Fixed CrossBar Contouring Handle, Right, Sm Stat
10889981152963Fixed CrossBar Contouring Handle, Left, Sm Stat
10889981152956Fixed CrossBar Inserter, Small Stature
10889981152949Axial Hook Inserter, Shaft, Small Stature
10889981152932Pedicle Finder, Small Stature
10889981152925Lamina/Transverse Process Finder, Small Stature
10889981152918Hook Pusher, Small Stature
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