NILE™ Alternative Fixation System 5401-84500
GUDID 10888857111592
Clamp Assembly
K2M, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10888857111592 |
| NIH Device Record Key | c1d967a6-de1d-453f-8eb2-9769b0ef543c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NILE™ Alternative Fixation System |
| Version Model Number | 5401-84500 |
| Catalog Number | 5401-84500 |
| 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 | 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(703)777-3155 |
| sgilbert@k2m.com | |
| Phone | +1(703)777-3155 |
| sgilbert@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 | |
| 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 Dimensions
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857111592 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143350
FDA Product Code
| OWI | Bone fixation cerclage, sublaminar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
[10888857111592]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [NILE™ Alternative Fixation System]
| 10888857269101 | Clamp Assembly Size Ø5.5 mm Rail |
| 10888857269095 | Clamp Assembly Size Ø5.5 mm |
| 10888857269088 | Clamp Assembly Size Ø4.5 mm Rail / Ø6.0 mm |
| 10888857269071 | Clamp Assembly Size Ø4.5 mm |
| 10888857157699 | Clamp Assembly |
| 10888857157682 | Clamp Assembly |
| 10888857156371 | Tensioner, Size 60 mm |
| 10888857156364 | Tensioner, Size 30 mm |
| 10888857111608 | Clamp Assembly |
| 10888857111592 | Clamp Assembly |
| 10888857000025 | Band |
| 10888857000018 | Band |
| 10888857034877 | Ratcheting T Handle, Square Drive |
Trademark Results [NILE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NILE 98807227 not registered Live/Pending |
Nile Global, Inc. 2024-10-17 |
 NILE 98202730 not registered Live/Pending |
Aphid, Inc. 2023-09-28 |
 NILE 97646349 not registered Live/Pending |
Aphid, Inc. 2022-10-25 |
 NILE 97251384 not registered Live/Pending |
Nile Global, Inc. 2022-02-03 |
 NILE 97250132 not registered Live/Pending |
Nile Global, Inc. 2022-02-02 |
 NILE 97243819 not registered Live/Pending |
Bath Authority LLC 2022-01-28 |
 NILE 97133060 not registered Live/Pending |
Nile AI, Inc. 2021-11-18 |
 NILE 97118749 not registered Live/Pending |
Subramanian, Sriram 2021-11-10 |
 NILE 90649531 not registered Live/Pending |
Walker Defense Research LLC 2021-04-16 |
 NILE 90467835 not registered Live/Pending |
Nile AI, Inc. 2021-01-15 |
 NILE 90252179 not registered Live/Pending |
Aphid, Inc. 2020-10-13 |
 NILE 88947470 not registered Live/Pending |
Aphid, Inc. 2020-06-04 |
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