CASCADIA™ Interbody System 6101-2123207NC-G2
GUDID 10888857161184
AN Interbody Convex, Size 12x32x7 mm
K2M, INC.
Vertebral body prosthesis| Primary Device ID | 10888857161184 |
| NIH Device Record Key | 06181975-ee34-4cbb-91c5-91e8bb25d4a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CASCADIA™ Interbody System |
| Version Model Number | 6101-2123207NC-G2 |
| Catalog Number | 6101-2123207NC-G2 |
| Company DUNS | 146060863 |
| Company Name | K2M, INC. |
| 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 | true |
| 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(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.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 Dimensions
| 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 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
| Width | 12 Millimeter |
| Height | 7 Millimeter |
| Length | 28 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857161184 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150481
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-09-02 |
On-Brand Devices [CASCADIA™ Interbody System]
| 10888857421899 | AL Interbody, Size 32x42mm, A=21mm, P=12mm, 20 Degrees |
| 10888857421882 | AL Interbody, Size 32x42mm, A=20mm, P=11mm, 20 Degrees |
| 10888857421875 | AL Interbody, Size 32x42mm, A=19mm, P=10mm, 20 Degrees |
| 10888857421868 | AL Interbody, Size 32x42mm, A=18mm, P=9mm, 20 Degrees |
| 10888857421851 | AL Interbody, Size 32x42mm, A=17mm, P=8mm, 20 Degrees |
| 10888857421844 | AL Interbody, Size 32x42mm, A=16mm, P=7mm, 20 Degrees |
| 10888857421837 | AL Interbody, Size 32x42mm, A=15mm, P=6mm, 20 Degrees |
| 10888857415775 | AL Interbody, Size 32x42mm, A=9mm, P=6mm, 10 Degrees |
| 10888857415768 | AL Interbody, Size 32x42mm, A=9mm, P=7mm, 5 Degrees |
| 10888857415751 | AL Interbody Convex, Size 32x42mm, A=9mm, P=9mm |
| 10888857415744 | AL Interbody, Size 32x42mm, A=10mm, P=7mm, 10 Degrees |
| 10888857415737 | AL Interbody, Size 32x42mm, A=10mm, P=8mm, 5 Degrees |
| 10888857415720 | AL Interbody Convex, Size 32x42mm, A=10mm, P=10mm |
| 10888857415713 | AL Interbody, Size 32x42mm, A=11mm, P=8mm, 10 Degrees |
| 10888857415706 | AL Interbody, Size 32x42mm, A=11mm, P=9mm, 5 Degrees |
| 10888857415690 | AL Interbody Convex, Size 32x42mm, A=11mm, P=11mm |
| 10888857415683 | AL Interbody, Size 32x42mm, A=12mm, P=9mm, 10 Degrees |
| 10888857415676 | AL Interbody, Size 32x42mm, A=12mm, P=10mm, 5 Degrees |
| 10888857415669 | AL Interbody Convex, Size 32x42mm, A=12mm, P=12mm |
| 10888857415652 | AL Interbody, Size 32x42mm, A=13mm, P=10mm, 10 Degrees |
| 10888857415645 | AL Interbody, Size 32x42mm, A=13mm, P=11mm, 5 Degrees |
| 10888857415638 | AL Interbody Convex, Size 32x42mm, A=13mm, P=13mm |
| 10888857415621 | AL Interbody, Size 32x42mm, A=18mm, P=12mm, 15 Degrees |
| 10888857415614 | AL Interbody, Size 32x42mm, A=14mm, P=11mm, 10 Degrees |
| 10888857415607 | AL Interbody, Size 32x42mm, A=14mm, P=12mm, 5 Degrees |
| 10888857415591 | AL Interbody Convex, Size 32x42mm, A=14mm, P=14mm |
| 10888857415584 | AL Interbody, Size 32x42mm, A=19mm, P=13mm, 15 Degrees |
| 10888857415577 | AL Interbody, Size 32x42mm, A=15mm, P=12mm, 10 Degrees |
| 10888857415560 | AL Interbody, Size 32x42mm, A=15mm, P=13mm, 5 Degrees |
| 10888857415553 | AL Interbody Convex, Size 32x42mm, A=15mm, P=15mm |
| 10888857415546 | AL Interbody, Size 32x42mm, A=20mm, P=14mm, 15 Degrees |
| 10888857415539 | AL Interbody, Size 32x42mm, A=16mm, P=13mm, 10 Degrees |
| 10888857415522 | AL Interbody, Size 32x42mm, A=16mm, P=14mm, 5 Degrees |
| 10888857415515 | AL Interbody Convex, Size 32x42mm, A=16mm, P=16mm |
| 10888857415508 | AL Interbody, Size 32x42mm, A=21mm, P=15mm, 15 Degrees |
| 10888857415492 | AL Interbody, Size 32x42mm, A=13mm, P=7mm, 15 Degrees |
| 10888857415485 | AL Interbody, Size 32x42mm, A=17mm, P=14mm, 10 Degrees |
| 10888857415478 | AL Interbody, Size 32x42mm, A=17mm, P=15mm, 5 Degrees |
| 10888857415461 | AL Interbody Convex, Size 32x42mm, A=17mm, P=17mm |
| 10888857415454 | AL Interbody, Size 32x42mm, A=14mm, P=8mm, 15 Degrees |
| 10888857415447 | AL Interbody, Size 32x42mm, A=18mm, P=15mm, 10 Degrees |
| 10888857415430 | AL Interbody, Size 32x42mm, A=18mm, P=16mm, 5 Degrees |
| 10888857415423 | AL Interbody Convex, Size 32x42mm, A=18mm, P=18mm |
| 10888857415416 | AL Interbody, Size 32x42mm, A=15mm, P=9mm, 15 Degrees |
| 10888857415409 | AL Interbody, Size 32x42mm, A=19mm, P=16mm, 10 Degrees |
| 10888857415393 | AL Interbody, Size 32x42mm, A=19mm, P=17mm, 5 Degrees |
| 10888857415386 | AL Interbody Convex, Size 32x42mm, A=19mm, P=19mm |
| 10888857415379 | AL Interbody, Size 32x42mm, A=16mm, P=10mm, 15 Degrees |
| 10888857415362 | AL Interbody, Size 32x42mm, A=20mm, P=17mm, 10 Degrees |
| 10888857415355 | AL Interbody, Size 32x42mm, A=20mm, P=18mm, 5 Degrees |
Trademark Results [CASCADIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CASCADIA 98804344 not registered Live/Pending |
Brooks Sports, Inc. 2024-10-16 |
 CASCADIA 98709169 not registered Live/Pending |
Mud Bay, Inc. 2024-08-21 |
 CASCADIA 98709157 not registered Live/Pending |
Mud Bay, Inc. 2024-08-21 |
 CASCADIA 98618280 not registered Live/Pending |
Brooks Sports, Inc. 2024-06-25 |
 CASCADIA 98107552 not registered Live/Pending |
Lightspeed Technologies, Inc. 2023-07-28 |
 CASCADIA 90791230 not registered Live/Pending |
Cascadia Brands Inc. 2021-06-23 |
 CASCADIA 88251850 not registered Dead/Abandoned |
Early Morning LLC 2019-01-07 |
 CASCADIA 87322277 5489378 Live/Registered |
K2M, Inc. 2017-02-02 |
 CASCADIA 86614464 5126702 Live/Registered |
Terminal Forest Products Ltd. 2015-04-29 |
 CASCADIA 86614281 not registered Dead/Abandoned |
Novelty Hill Winery, LLC 2015-04-29 |
 CASCADIA 85513984 4168104 Dead/Cancelled |
Becker Designed, Inc. 2012-01-11 |
 CASCADIA 85475814 4362004 Live/Registered |
Rodda Paint Co. 2011-11-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.