| Primary Device ID | 10889981276607 |
| NIH Device Record Key | c76b1bee-2034-4641-9440-aca7ca9b73e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoreline ACS |
| Version Model Number | 85-2805 |
| Catalog Number | 85-2805 |
| 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 | |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981276607 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
[10889981276607]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-25 |
| Device Publish Date | 2022-02-17 |
| 10889981162573 | Tap, 20mm |
| 10889981162566 | Tap, 18mm |
| 10889981162559 | Tap, 10mm |
| 10889981162542 | Drill, 20mm |
| 10889981162535 | Drill, 18mm |
| 10889981162528 | Drill, 10mm |
| 10889981161996 | Tray, Trials and Rasp Tray |
| 10889981161989 | Tray, Screw Prep and Final Tightening |
| 10889981161972 | Tray, Plates, Screws, and Locking Covers |
| 10889981161965 | Case Lid |
| 10889981161958 | Case, Shoreline Instrument and Fixation Tray |
| 10889981149635 | Shoreline Hyperlordotic Modular Trial Tray |
| 10889981149499 | Plate Assembly Tool |
| 10889981149277 | Plate Template |
| 10889981146382 | Angled DTS Awl |
| 10889981146375 | Angled DTS Driver |
| 10889981144982 | 15° Modular Trial Caddy |
| 10889981144975 | 10° Modular Trial Caddy |
| 10889981144968 | Shoreline Hyperlordotic Instrument Tray |
| 10889981144852 | Modular Trial 20x15x12mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144845 | Modular Trial 20x15x11mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144838 | Modular Trial 20x15x10mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144821 | Modular Trial 20x15x9mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144814 | Modular Trial 20x15x8mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144807 | Modular Trial 18x15x12mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144791 | Modular Trial 18x15x11mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144784 | Modular Trial 18x15x10mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144777 | Modular Trial 18x15x9mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144760 | Modular Trial 18x15x8mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144753 | Modular Trial 16x14x12mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144746 | Modular Trial 16x14x11mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144739 | Modular Trial 16x14x10mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144722 | Modular Trial 16x14x9mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144715 | Modular Trial 16x14x8mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144708 | Modular Trial 16x14x7mm, 15 Deg Lordosis, w/ Depth Stop |
| 10889981144692 | Modular Trial 20x15x12mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144685 | Modular Trial 20x15x11mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144678 | Modular Trial 20x15x10mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144661 | Modular Trial 20x15x9mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144654 | Modular Trial 20x15x8mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144647 | Modular Trial 20x15x7mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144630 | Modular Trial 20x15x6mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144623 | Modular Trial 18x15x12mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144616 | Modular Trial 18x15x11mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144609 | Modular Trial 18x15x10mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144593 | Modular Trial 18x15x9mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144586 | Modular Trial 18x15x8mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144579 | Modular Trial 18x15x7mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144562 | Modular Trial 18x15x6mm, 10 Deg Lordosis, w/ Depth Stop |
| 10889981144555 | Modular Trial 16x14x12mm, 10 Deg Lordosis, w/ Depth Stop |