| Primary Device ID | 10889981076047 |
| NIH Device Record Key | a4dd31ec-8b7c-420f-92f8-17daf4691640 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Laminoplasty |
| Version Model Number | 52-2312 |
| Catalog Number | 52-2312 |
| 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 |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981076047 [Primary] |
| NQW | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
[10889981076047]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-15 |
| 10889981135010 | Graft Block Holder |
| 10889981129811 | Laminoplasty Graft Plate, Side by Side Caddy BOM |
| 10889981129699 | Laminoplasty Graft Plate, Single Caddy BOM |
| 10889981127824 | Laminoplasty Graft Plate, in-Line Caddy BOM |
| 10889981123895 | Laminoplasty 14mm Plate Caddy |
| 10889981120597 | Stop Drill, 11mm L |
| 10889981119034 | Laminoplasty Instrument Set |
| 10889981096113 | 6mm Mouth, Single Plate Caddy |
| 10889981096106 | 4mm Mouth, Single Plate Caddy |
| 10889981096090 | Optional Plate and Screw Caddy |
| 10889981096083 | Self Drilling Lamina Screw Caddy |
| 10889981096076 | Hinge Plate Implant Caddy |
| 10889981096069 | 6mm Mouth, In-Line Implant Caddy |
| 10889981096052 | 4mm Mouth, In-Line Implant Caddy |
| 10889981096045 | 6mm Mouth, Side by Side Implant Caddy |
| 10889981096038 | 4mm Mouth, Side by Side Implant Caddy |
| 10889981096021 | Implant Tray |
| 10889981096014 | Instrument Tray |
| 10889981095963 | Screwdriver |
| 10889981095956 | Universal Handle |
| 10889981095932 | Plate Holder with AIO Guide |
| 10889981095925 | Plate Holder, Straight |
| 10889981095918 | Plate Holder |
| 10889981095901 | Sounder/Probe |
| 10889981095895 | Stop Drill, 9mm L |
| 10889981095888 | Stop Drill, 7mm L |
| 10889981095871 | Stop Drill, 5mm L |
| 10889981095857 | Short Drill, 5mm L |
| 10889981095840 | Drill Guide |
| 10889981076047 | Graft Plate, Single, 12mm |
| 10889981076023 | Graft Plate, Single, 10mm |
| 10889981076009 | Graft Plate, Single, 8mm |
| 10889981075989 | Graft Plate, Single, 6mm |
| 10889981075934 | Graft Plate, In-Line, 12mm |
| 10889981075910 | Graft Plate, In-Line, 10mm |
| 10889981075897 | Graft Plate, In-Line, 8mm |
| 10889981075873 | Graft Plate, In-Line, 6mm |
| 10889981075828 | Graft Plate, Side by Side, 12mm |
| 10889981075804 | Graft Plate, Side by Side, 10mm |
| 10889981075781 | Graft Plate, Side by Side, 8mm |
| 10889981075767 | Graft Plate, Side by Side, 6mm |
| 10889981062637 | Laminoplasty Optional Implant Set |
| 10889981062620 | Laminoplasty Implant Set |
| 10889981062170 | Lamina Sizing Trial, 6mm |
| 10889981062163 | Lamina Sizing Trial, 4mm |
| 10889981062156 | Plate Sizing Trial, 16mm L |
| 10889981062149 | Plate Sizing Trial, 14mm L |
| 10889981062132 | Plate Sizing Trial, 12mm L |
| 10889981062125 | Plate Sizing Trial, 10mm L |
| 10889981062118 | Plate Sizing Trial, 8mm L |