Laminoplasty 52-0306

GUDID 10889981061487

Single Plate, 4mm Mouth, 6mm L

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile
Primary Device ID10889981061487
NIH Device Record Key95cf7a4a-3542-472b-bfa0-8b7c457b1fe6
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaminoplasty
Version Model Number52-0306
Catalog Number52-0306
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
GS110889981061487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981061487]

Moist Heat or Steam Sterilization


[10889981061487]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Laminoplasty]

10889981135010Graft Block Holder
10889981129811Laminoplasty Graft Plate, Side by Side Caddy BOM
10889981129699Laminoplasty Graft Plate, Single Caddy BOM
10889981127824Laminoplasty Graft Plate, in-Line Caddy BOM
10889981123895Laminoplasty 14mm Plate Caddy
10889981120597Stop Drill, 11mm L
10889981119034Laminoplasty Instrument Set
108899810961136mm Mouth, Single Plate Caddy
108899810961064mm Mouth, Single Plate Caddy
10889981096090Optional Plate and Screw Caddy
10889981096083Self Drilling Lamina Screw Caddy
10889981096076Hinge Plate Implant Caddy
108899810960696mm Mouth, In-Line Implant Caddy
108899810960524mm Mouth, In-Line Implant Caddy
108899810960456mm Mouth, Side by Side Implant Caddy
108899810960384mm Mouth, Side by Side Implant Caddy
10889981096021Implant Tray
10889981096014Instrument Tray
10889981095963Screwdriver
10889981095956Universal Handle
10889981095932Plate Holder with AIO Guide
10889981095925Plate Holder, Straight
10889981095918Plate Holder
10889981095901Sounder/Probe
10889981095895Stop Drill, 9mm L
10889981095888Stop Drill, 7mm L
10889981095871Stop Drill, 5mm L
10889981095857Short Drill, 5mm L
10889981095840Drill Guide
10889981076047Graft Plate, Single, 12mm
10889981076023Graft Plate, Single, 10mm
10889981076009Graft Plate, Single, 8mm
10889981075989Graft Plate, Single, 6mm
10889981075934Graft Plate, In-Line, 12mm
10889981075910Graft Plate, In-Line, 10mm
10889981075897Graft Plate, In-Line, 8mm
10889981075873Graft Plate, In-Line, 6mm
10889981075828Graft Plate, Side by Side, 12mm
10889981075804Graft Plate, Side by Side, 10mm
10889981075781Graft Plate, Side by Side, 8mm
10889981075767Graft Plate, Side by Side, 6mm
10889981062637Laminoplasty Optional Implant Set
10889981062620Laminoplasty Implant Set
10889981062170Lamina Sizing Trial, 6mm
10889981062163Lamina Sizing Trial, 4mm
10889981062156Plate Sizing Trial, 16mm L
10889981062149Plate Sizing Trial, 14mm L
10889981062132Plate Sizing Trial, 12mm L
10889981062125Plate Sizing Trial, 10mm L
10889981062118Plate Sizing Trial, 8mm L

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