NILE™ Proximal Fixation System SP-2466
GUDID 10888857384156
Tensioner
K2M, INC.
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 10888857384156 |
| NIH Device Record Key | 33322d48-1f73-4811-868b-a6cab9bc55cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NILE™ Proximal Fixation System |
| Version Model Number | SP-2466 |
| Catalog Number | SP-2466 |
| 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 | |
| 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 | 10888857384156 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161332
FDA Product Code
| OWI | Bone fixation cerclage, sublaminar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
Moist Heat or Steam Sterilization
[10888857384156]
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 | 2017-11-30 |
On-Brand Devices [NILE™ Proximal Fixation System]
| 10888857384156 | Tensioner |
| 10888857306745 | Anchor Inserter |
| 10888857306738 | Tensioner |
| 10888857291287 | Medial Offset Connector |
| 10888857291270 | Semi-Adj Transverse Connector Single Slot, Size 28 mm |
| 10888857291263 | Semi-Adj Transverse Connector Dual Slot, Size 34 mm |
| 10888857291256 | Semi-Adj Transverse Connector Dual Slot, Size 40 mm |
| 10888857291249 | Semi-Adj Transverse Connector Single Slot, Size 31 mm |
| 10888857291232 | Semi-Adj Transverse Connector Dual Slot, Size 37 mm |
| 10888857291225 | Semi-Adj Transverse Connector Dual Slot, Size 43 mm |
| 10888857291195 | Transverse Connector, Adjustable, Size 45 mm - 48 mm |
| 10888857291188 | Transverse Connector, Adjustable, Size 50 mm - 58 mm |
| 10888857291171 | Transverse Connector, Adjustable, Size 47 mm - 52 mm |
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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