TERRA NOVA® MI Access System K2-15-2017-03
GUDID 10888857185692
Retractor/Distractor (Long), Size 70 mm Long
K2M, INC.
Surgical retractor/retraction system blade, reusable| Primary Device ID | 10888857185692 |
| NIH Device Record Key | a7d3e30f-ed03-49e1-b176-f55c39a82ca9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TERRA NOVA® MI Access System |
| Version Model Number | K2-15-2017-03 |
| Catalog Number | K2-15-2017-03 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857185692 [Primary] |
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
[10888857185692]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-08 |
| Device Publish Date | 2021-01-29 |
On-Brand Devices [TERRA NOVA® MI Access System]
| 10888857291089 | Angled Blade, Size 70 mm, 40° |
| 10888857291072 | Angled Blade, Size 70 mm, 30° |
| 10888857291065 | Angled Blade, Size 70 mm, 25° |
| 10888857291058 | Angled Blade, Size 60 mm, 40° |
| 10888857291041 | Angled Blade, Size 60 mm, 30° |
| 10888857291034 | Angled Blade, Size 60 mm, 25° |
| 10888857291027 | Angled Blade, Size 50 mm, 30° |
| 10888857291010 | Angled Blade, Size 50 mm, 25° |
| 10888857247956 | Angled Blade, Size 50 mm, 40° |
| 10888857279193 | Medium Retractor Distractor Angled 15°, Size 90 mm |
| 10888857279186 | Medium Retractor Distractor Angled 15°, Size 80 mm |
| 10888857279179 | Medium Retractor Distractor Angled 15°, Size 70 mm |
| 10888857279162 | Medium Retractor Distractor Angled 15°, Size 60 mm |
| 10888857279155 | Medium Retractor Distractor Angled 15°, Size 50 mm |
| 10888857212138 | Medium Retractor Distractor Angled 15°, Size 90 mm, Long |
| 10888857212121 | Medium Retractor Distractor Angled 15°, Size 80 mm, Long |
| 10888857212114 | Medium Retractor Distractor Angled 15°, Size 70 mm, Long |
| 10888857212107 | Medium Retractor Distractor Angled 15°, Size 60 mm, Long |
| 10888857212091 | Medium Retractor Distractor Angled 15°, Size 50 mm, Long |
| 10888857185760 | Medium Retractor Distractor, Size 50 mm |
| 10888857185753 | Medium Retractor Distractor, Size 60 mm |
| 10888857185746 | Medium Retractor Distractor, Size 70 mm |
| 10888857185739 | Medium Retractor Distractor, Size 80 mm |
| 10888857185722 | Medium Retractor Distractor, Size 90 mm |
| 10888857185715 | Retractor/Distractor (Long), Size 50 mm |
| 10888857185708 | Retractor/Distractor (Long), Size 60 mm |
| 10888857185692 | Retractor/Distractor (Long), Size 70 mm Long |
| 10888857185685 | Retractor/Distractor (Long), Size 80 mm Long |
| 10888857185678 | Retractor/Distractor (Long), Size 90 mm Long |
| 10888857185654 | Screw Based Retractor Blade (Left), Size 50 mm |
| 10888857185647 | Screw Based Retractor Blade (Left), Size 60 mm |
| 10888857185630 | Screw Based Retractor Blade (Left), Size 70 mm |
| 10888857185623 | Screw Based Retractor Blade (Left), Size 80 mm |
| 10888857185616 | Screw Based Retractor Blade (Left), Size 90 mm |
| 10888857185609 | Screw Based Retractor Blade (Right), Size 50 mm |
| 10888857185593 | Screw Based Retractor Blade (Right), Size 60 mm |
| 10888857185586 | Screw Based Retractor Blade (Right), Size 70 mm |
| 10888857185579 | Screw Based Retractor Blade (Right), Size 80 mm |
| 10888857185562 | Screw Based Retractor Blade (Right), Size 90 mm |
| 10888857158313 | Guide Wire, Size Ø1.4 x 230 mm |
| 10888857157590 | Straight Blade, Size 23 x 30 mm |
| 10888857157262 | Angled Blade, Size 23 x 30 mm |
| 10888857020580 | Medium Retractor Distractor, Size 50 mm |
| 10888857020573 | Medium Retractor Distractor, Size 60 mm |
| 10888857020566 | Medium Retractor Distractor, Size 70 mm |
| 10888857020559 | Medium Retractor Distractor, Size 80 mm |
| 10888857020542 | Medium Retractor Distractor, Size 90 mm |
| 10888857020535 | Retractor/Distractor (Long), Size 50 mm |
| 10888857020528 | Retractor/Distractor (Long), Size 60 mm |
| 10888857020511 | Retractor/Distractor (Long), Size 70 mm Long |
Trademark Results [TERRA NOVA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TERRA NOVA 98772886 not registered Live/Pending |
Royal Tears 2024-09-26 |
 TERRA NOVA 98216125 not registered Live/Pending |
Michael Malul, LLC 2023-10-10 |
 TERRA NOVA 97570318 not registered Live/Pending |
NutriRise Inc. 2022-08-30 |
 TERRA NOVA 97324949 not registered Live/Pending |
Terra Nova Accelerator, LLC 2022-03-22 |
 TERRA NOVA 97150051 not registered Live/Pending |
Williams, Jason 2021-12-01 |
 TERRA NOVA 86893104 not registered Dead/Abandoned |
Tierra y Fuego, Inc. 2016-02-01 |
 TERRA NOVA 86348138 not registered Dead/Abandoned |
Terra Nova, Inc. 2014-07-25 |
 TERRA NOVA 79331212 not registered Live/Pending |
ABB B.V. 2021-12-20 |
 TERRA NOVA 79154841 4729739 Live/Registered |
Arnold André GmbH & Co. KG 2014-08-05 |
 TERRA NOVA 78755782 3309133 Dead/Cancelled |
Winning Moves Inc. 2005-11-17 |
 TERRA NOVA 77430406 3604025 Live/Registered |
K2M, Inc. 2008-03-25 |
 TERRA NOVA 77268373 3517703 Live/Registered |
Terra Nova Equipment Limited 2007-08-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.