NorthStar PC1-304540
GUDID 10889981198152
Ext. Tab Poly. Screw, 4.5mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10889981198152 |
| NIH Device Record Key | 29417628-81d1-4b4b-9d30-954aadd2c29f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NorthStar |
| Version Model Number | PC1-304540 |
| Catalog Number | PC1-304540 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981198152 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193615
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
[10889981198152]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
On-Brand Devices [NorthStar]
| 10889981231750 | W Dual, Parallel, Top Loading to 5.5/6.0mm |
| 10889981231743 | W Dual, Parallel, Top Loading |
| 10889981231736 | W Parallel Top Loading to 5.5/6.0mm |
| 10889981231729 | W Parallel Top Loading |
| 10889981221010 | Transition Tray Bottom Level Insert |
| 10889981217280 | Transition CoCr Rod, 4.0mm to 6.0mm, 500mm |
| 10889981217273 | Transition CoCr Rod, 4.0mm to 5.5mm, 500mm |
| 10889981217266 | Transition CoCr Rod, 3.5mm to 6.0mm, 500mm |
| 10889981217259 | Transition CoCr Rod, 3.5mm to 5.5mm, 500mm |
| 10889981214265 | Rod-to-Rod Connector, 4.0mm XL |
| 10889981214258 | Rod-to-Rod Connector, 3.5mm XL |
| 10889981200220 | Transition Tray Top Level Insert |
| 10889981200206 | Transition Tray Case |
| 10889981200190 | Implant Tray Insert |
| 10889981200152 | Implant Tray Case |
| 10889981200145 | Instrument Tray Top Level Insert |
| 10889981200121 | Instrument Tray Bottom Level Insert |
| 10889981200107 | Instrument Tray Case |
| 10889981200091 | Occ Tray Insert |
| 10889981200077 | OCC Tray Case |
| 10889981200060 | Transition Implant Caddy |
| 10889981200053 | 5.5mm Favored Angle Screw Caddy |
| 10889981200046 | 4.5mm Favored Angle Screw Caddy |
| 10889981200039 | 3.5mm/4.0mm Extended Tab Screw Caddy |
| 10889981200022 | 4.0mm Contoured Rod Caddy |
| 10889981200015 | 3.5mm Contoured Rod Caddy |
| 10889981199999 | Rod to Screw Connector Caddy |
| 10889981199982 | Screw to Screw Connector Caddy |
| 10889981199975 | Set Screw Caddy |
| 10889981199968 | 3.5mm Smooth Shank Screw Caddy |
| 10889981199951 | 4.0mm Poly Screw Caddy |
| 10889981199944 | 3.5mm Poly Screw Caddy |
| 10889981199920 | OCC Plate Caddy |
| 10889981199913 | OCC Screw Caddy |
| 10889981199043 | Transition Ti Rod, 4.0mm to 6.0mm, 500mm |
| 10889981199036 | Transition Ti Rod, 4.0mm to 5.5mm, 500mm |
| 10889981199029 | Transition Ti Rod, 3.5mm to 6.0mm, 500mm |
| 10889981199012 | Transition Ti Rod, 3.5mm to 5.5mm, 500mm |
| 10889981199005 | Contoured CoCr OCC Rod, 4.0mm x 170mm x 70 Deg |
| 10889981198992 | Contoured CoCr OCC Rod, 4.0mm x 170mm x 60 Deg |
| 10889981198985 | Contoured CoCr Rod, 4.0mm x 95mm |
| 10889981198978 | Contoured CoCr Rod, 4.0mm x 90mm |
| 10889981198961 | Contoured CoCr Rod, 4.0mm x 85mm |
| 10889981198954 | Contoured CoCr Rod, 4.0mm x 80mm |
| 10889981198947 | Contoured CoCr Rod, 4.0mm x 75mm |
| 10889981198930 | Contoured CoCr Rod, 4.0mm x 70mm |
| 10889981198923 | Contoured CoCr Rod, 4.0mm x 65mm |
| 10889981198916 | Contoured CoCr Rod, 4.0mm x 60mm |
| 10889981198909 | Contoured CoCr Rod, 4.0mm x 55mm |
| 10889981198893 | Contoured CoCr Rod, 4.0mm x 50mm |
Trademark Results [NorthStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NORTHSTAR 98482790 not registered Live/Pending |
Northstar Travel Media, LLC 2024-04-03 |
 NORTHSTAR 98246299 not registered Live/Pending |
NorthStar Christian Academy 2023-10-30 |
 NORTHSTAR 98169253 not registered Live/Pending |
North Star Fertility Partners LLC 2023-09-07 |
 NORTHSTAR 97782556 not registered Live/Pending |
Imricor Medical Systems, Inc. 2023-02-06 |
 NORTHSTAR 97604942 not registered Live/Pending |
NorthStar Clean Energy Company 2022-09-23 |
 NORTHSTAR 97591165 not registered Live/Pending |
Physicians Group Management, LLC 2022-09-14 |
 NORTHSTAR 97016556 not registered Live/Pending |
Northstar Load Cell and Scale LLC 2021-09-08 |
 NORTHSTAR 97016486 not registered Live/Pending |
Northstar Load Cell and Scale LLC 2021-09-08 |
 NORTHSTAR 90840189 not registered Live/Pending |
The Coleman Company, Inc. 2021-07-21 |
 NORTHSTAR 90691676 not registered Live/Pending |
Physicians Group Management, Llc 2021-05-05 |
 NORTHSTAR 90455870 not registered Live/Pending |
AIM Directional Services, LLC 2021-01-08 |
 NORTHSTAR 90398259 not registered Live/Pending |
Northstar Scaffold Services Inc. 2020-12-21 |
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