| Primary Device ID | 07613327506808 |
| NIH Device Record Key | eb27aa5c-66c3-44ca-bac1-a46df69d0599 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CASCADIA Interbody System |
| Version Model Number | 48019900 |
| Catalog Number | 48019900 |
| Company DUNS | 146060863 |
| Company Name | K2M, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327506808 [Primary] |
| GS1 | 10888857596160 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
[07613327506808]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-03 |
| Device Publish Date | 2024-04-25 |
| 10888857551817 | Inserter Inner Shaft |
| 10888857551800 | Inserter Outer Shaft |
| 10888857462168 | ALIF Trial Inserter |
| 10888857431461 | Tapered Driver Size 20 |
| 10888857383838 | Inserter Blade Tether |
| 10888857383821 | Plate Assembly Final Tightener |
| 10888857383715 | Plate Assembly Driver Tapered |
| 10888857320673 | Graft Contaiment Ramp Size 22 mm, Stop |
| 10888857272170 | Implant Inserter |
| 10888857562943 | Caddy |
| 10888857562936 | Caddy |
| 10888857562929 | Caddy |
| 10888857562912 | Caddy |
| 10888857557277 | Inserter ATP, 35° |
| 10888857557260 | Inserter ATP, 25° |
| 10888857556072 | Inserter Inner Shaft ATP |
| 10888857554269 | Untightening Ring Inserter |
| 07613327506808 | Case Lid |
| 07613327506761 | Instrument Case |
| 07613327506624 | Instrument Case |
| 07613327506570 | Instrument Case |