Shoreline RT 85-6509
GUDID 10889981164119
Interbody, 18x15x9mm, 10 Degree, RT
SEASPINE ORTHOPEDICS CORPORATION
Metal-polymer composite spinal interbody fusion cage| Primary Device ID | 10889981164119 |
| NIH Device Record Key | b63bda72-5d2d-48ff-8b23-734c3f98f62d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoreline RT |
| Version Model Number | 85-6509 |
| Catalog Number | 85-6509 |
| 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 | 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(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 | 10889981164119 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183083
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-25 |
| Device Publish Date | 2021-03-17 |
On-Brand Devices [Shoreline RT]
| 10889981164393 | Interbody, 20x15x12mm, 15 Degree, RT |
| 10889981164386 | Interbody, 20x15x11mm, 15 Degree, RT |
| 10889981164379 | Interbody, 20x15x10mm, 15 Degree, RT |
| 10889981164362 | Interbody, 20x15x9mm, 15 Degree, RT |
| 10889981164355 | Interbody, 20x15x8mm, 15 Degree, RT |
| 10889981164348 | Interbody, 20x15x12mm, 10 Degree, RT |
| 10889981164331 | Interbody, 20x15x11mm, 10 Degree, RT |
| 10889981164324 | Interbody, 20x15x10mm, 10 Degree, RT |
| 10889981164317 | Interbody, 20x15x9mm, 10 Degree, RT |
| 10889981164300 | Interbody, 20x15x8mm, 10 Degree, RT |
| 10889981164294 | Interbody, 20x15x7mm, 10 Degree, RT |
| 10889981164287 | Interbody, 20x15x6mm, 10 Degree, RT |
| 10889981164270 | Interbody, 20x15x12mm, 7 Degree, RT |
| 10889981164263 | Interbody, 20x15x11mm, 7 Degree, RT |
| 10889981164256 | Interbody, 20x15x10mm, 7 Degree, RT |
| 10889981164249 | Interbody, 20x15x9mm, 7 Degree, RT |
| 10889981164232 | Interbody, 20x15x8mm, 7 Degree, RT |
| 10889981164225 | Interbody, 20x15x7mm, 7 Degree, RT |
| 10889981164218 | Interbody, 20x15x6mm, 7 Degree, RT |
| 10889981164201 | Interbody, 20x15x5mm, 7 Degree, RT |
| 10889981164195 | Interbody, 18x15x12mm, 15 Degree, RT |
| 10889981164188 | Interbody, 18x15x11mm, 15 Degree, RT |
| 10889981164171 | Interbody, 18x15x10mm, 15 Degree, RT |
| 10889981164164 | Interbody, 18x15x9mm, 15 Degree, RT |
| 10889981164157 | Interbody, 18x15x8mm, 15 Degree, RT |
| 10889981164140 | Interbody, 18x15x12mm, 10 Degree, RT |
| 10889981164133 | Interbody, 18x15x11mm, 10 Degree, RT |
| 10889981164126 | Interbody, 18x15x10mm, 10 Degree, RT |
| 10889981164119 | Interbody, 18x15x9mm, 10 Degree, RT |
| 10889981164102 | Interbody, 18x15x8mm, 10 Degree, RT |
| 10889981164096 | Interbody, 18x15x7mm, 10 Degree, RT |
| 10889981164089 | Interbody, 18x15x6mm, 10 Degree, RT |
| 10889981164072 | Interbody, 18x15x12mm, 7 Degree, RT |
| 10889981164065 | Interbody, 18x15x11mm, 7 Degree, RT |
| 10889981164058 | Interbody, 18x15x10mm, 7 Degree, RT |
| 10889981164041 | Interbody, 18x15x9mm, 7 Degree, RT |
| 10889981164034 | Interbody, 18x15x8mm, 7 Degree, RT |
| 10889981164027 | Interbody, 18x15x7mm, 7 Degree, RT |
| 10889981164010 | Interbody, 18x15x6mm, 7 Degree, RT |
| 10889981164003 | Interbody, 18x15x5mm, 7 Degree, RT |
| 10889981163990 | Interbody, 16x14x12mm, 15 Degree, RT |
| 10889981163983 | Interbody, 16x14x11mm, 15 Degree, RT |
| 10889981163976 | Interbody, 16x14x10mm, 15 Degree, RT |
| 10889981163969 | Interbody, 16x14x9mm, 15 Degree, RT |
| 10889981163952 | Interbody, 16x14x8mm, 15 Degree, RT |
| 10889981163945 | Interbody, 16x14x7mm, 15 Degree, RT |
| 10889981163938 | Interbody, 16x14x12mm, 10 Degree, RT |
| 10889981163921 | Interbody, 16x14x11mm, 10 Degree, RT |
| 10889981163914 | Interbody, 16x14x10mm, 10 Degree, RT |
| 10889981163907 | Interbody, 16x14x9mm, 10 Degree, RT |
Trademark Results [Shoreline RT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHORELINE RT 88511680 not registered Live/Pending |
SeaSpine Orthopedics Corporation 2019-07-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.