NorthStar PC1-504035

GUDID 10889981198480

Contoured Ti Rod, 4.0mm x 35mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10889981198480
NIH Device Record Key8ac05dce-aeb4-49f2-986c-ff1e081af7fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorthStar
Version Model NumberPC1-504035
Catalog NumberPC1-504035
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]
GS110889981198480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


[10889981198480]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [NorthStar]

10889981231750W Dual, Parallel, Top Loading to 5.5/6.0mm
10889981231743W Dual, Parallel, Top Loading
10889981231736W Parallel Top Loading to 5.5/6.0mm
10889981231729W Parallel Top Loading
10889981221010Transition Tray Bottom Level Insert
10889981217280Transition CoCr Rod, 4.0mm to 6.0mm, 500mm
10889981217273Transition CoCr Rod, 4.0mm to 5.5mm, 500mm
10889981217266Transition CoCr Rod, 3.5mm to 6.0mm, 500mm
10889981217259Transition CoCr Rod, 3.5mm to 5.5mm, 500mm
10889981214265Rod-to-Rod Connector, 4.0mm XL
10889981214258Rod-to-Rod Connector, 3.5mm XL
10889981200220Transition Tray Top Level Insert
10889981200206Transition Tray Case
10889981200190Implant Tray Insert
10889981200152Implant Tray Case
10889981200145Instrument Tray Top Level Insert
10889981200121Instrument Tray Bottom Level Insert
10889981200107Instrument Tray Case
10889981200091Occ Tray Insert
10889981200077OCC Tray Case
10889981200060Transition Implant Caddy
108899812000535.5mm Favored Angle Screw Caddy
108899812000464.5mm Favored Angle Screw Caddy
108899812000393.5mm/4.0mm Extended Tab Screw Caddy
108899812000224.0mm Contoured Rod Caddy
108899812000153.5mm Contoured Rod Caddy
10889981199999Rod to Screw Connector Caddy
10889981199982Screw to Screw Connector Caddy
10889981199975Set Screw Caddy
108899811999683.5mm Smooth Shank Screw Caddy
108899811999514.0mm Poly Screw Caddy
108899811999443.5mm Poly Screw Caddy
10889981199920OCC Plate Caddy
10889981199913OCC Screw Caddy
10889981199043Transition Ti Rod, 4.0mm to 6.0mm, 500mm
10889981199036Transition Ti Rod, 4.0mm to 5.5mm, 500mm
10889981199029Transition Ti Rod, 3.5mm to 6.0mm, 500mm
10889981199012Transition Ti Rod, 3.5mm to 5.5mm, 500mm
10889981199005Contoured CoCr OCC Rod, 4.0mm x 170mm x 70 Deg
10889981198992Contoured CoCr OCC Rod, 4.0mm x 170mm x 60 Deg
10889981198985Contoured CoCr Rod, 4.0mm x 95mm
10889981198978Contoured CoCr Rod, 4.0mm x 90mm
10889981198961Contoured CoCr Rod, 4.0mm x 85mm
10889981198954Contoured CoCr Rod, 4.0mm x 80mm
10889981198947Contoured CoCr Rod, 4.0mm x 75mm
10889981198930Contoured CoCr Rod, 4.0mm x 70mm
10889981198923Contoured CoCr Rod, 4.0mm x 65mm
10889981198916Contoured CoCr Rod, 4.0mm x 60mm
10889981198909Contoured CoCr Rod, 4.0mm x 55mm
10889981198893Contoured CoCr Rod, 4.0mm x 50mm

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