NILE™ Alternative Fixation System 5401-90003
GUDID 10888857156364
Tensioner, Size 30 mm
K2M, INC.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 10888857156364 |
| NIH Device Record Key | 21a9c696-a5b5-452b-bcfd-c92e721bf7e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NILE™ Alternative Fixation System |
| Version Model Number | 5401-90003 |
| Catalog Number | 5401-90003 |
| 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 | 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(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| 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 | |
| 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
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857156364 [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 |
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
Moist Heat or Steam Sterilization
[10888857156364]
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 | 2016-09-16 |
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 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 |
 NILE 88739729 not registered Live/Pending |
Aphid, Inc. 2019-12-26 |
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