| Primary Device ID | 10888857551824 |
| NIH Device Record Key | 1ef802e3-ae60-4034-9149-5cbb1bb1c4e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oasys® |
| Version Model Number | PRO-1222 |
| Catalog Number | PRO-1222 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857551824 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
[10888857551824]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-23 |
| Device Publish Date | 2025-01-15 |
| 10888857469648 - TERRA NOVA® MI Access System | 2025-09-19 Retractor Arm |
| 10888857469655 - TERRA NOVA® MI Access System | 2025-09-19 Retractor Frame |
| 10888857017214 - ALEUTIAN® Interbody Systems | 2025-09-17 Disc Spreader Size 9 mm |
| 10888857017221 - ALEUTIAN® Interbody Systems | 2025-09-17 Disc Spreader Size 11 mm |
| 10888857017245 - ALEUTIAN® Interbody Systems | 2025-09-17 Disc Spreader Size 13 mm |
| 10888857017290 - ALEUTIAN® Interbody Systems | 2025-09-17 Anterior Pituitary Rongeur (Up) Size 13" 4 mm 45° |
| 10888857115255 - ALEUTIAN® Interbody Systems | 2025-09-17 Rasp Size 13x24x30 mm |
| 10888857115262 - ALEUTIAN® Interbody Systems | 2025-09-17 Rasp Size 15x24x30 mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OASYS 98225306 not registered Live/Pending |
U.S. Peroxide, LLC 2023-10-16 |
![]() OASYS 97828564 not registered Live/Pending |
Nationwide Marketing Group, LLC 2023-03-08 |
![]() OASYS 97420849 not registered Live/Pending |
Panasonic Corporation of North America 2022-05-20 |
![]() OASYS 97346901 not registered Live/Pending |
SES Foam, LLC 2022-04-05 |
![]() OASYS 97346900 not registered Live/Pending |
SES Foam, LLC 2022-04-05 |
![]() OASYS 90853376 not registered Live/Pending |
OFI Testing Equipment, Inc. 2021-07-28 |
![]() OASYS 90693080 not registered Live/Pending |
Oasys Services LLC 2021-05-06 |
![]() OASYS 90333964 not registered Live/Pending |
Bryan Guy 2020-11-20 |
![]() OASYS 88077575 not registered Live/Pending |
DTCC ITP LLC 2018-08-14 |
![]() OASYS 87940231 not registered Dead/Abandoned |
Stereobot 2018-05-29 |
![]() OASYS 87608740 5506588 Live/Registered |
Oasys, LLC 2017-09-14 |
![]() OASYS 86003158 4574683 Live/Registered |
Oneworld Accuracy Inc. 2013-07-05 |