PYRENEES® Cervical Plate System 201-04012C
GUDID 10888857026636
Semi-Constrained, Self Tapping Screw
K2M, INC.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10888857026636 |
| NIH Device Record Key | d19522c9-2ef1-42e1-91e6-6e3e84d58687 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRENEES® Cervical Plate System |
| Version Model Number | 201-04012C |
| Catalog Number | 201-04012C |
| 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 |
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857026636 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092474
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
Moist Heat or Steam Sterilization
[10888857026636]
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 [PYRENEES® Cervical Plate System]
| 10888857432413 | Plate Holder |
| 10888857427525 | Adjustable Drill Guide |
| 10888857412408 | Double Barrel Drill Guide |
| 10888857412392 | Single Barrel Drill Guide, Fixed |
| 10888857381735 | Plate Holder |
| 10888857327139 | Screw, Self-Tapping, Size Ø5.0x26 mm |
| 10888857327122 | Screw, Self-Tapping, Size Ø5.0x24 mm |
| 10888857327115 | Screw, Self-Tapping, Size Ø4.75x26 mm |
| 10888857327108 | Screw, Self-Tapping, Size Ø4.75x24 mm |
| 10888857327092 | Screw, Self-Tapping, Size Ø4.5x26 mm |
| 10888857327085 | Screw, Self-Tapping, Size Ø4.5x24 mm |
| 10888857327078 | Screw, Self-Tapping, Size Ø5.0x26 mm |
| 10888857327061 | Screw, Self-Tapping, Size Ø5.0x24 mm |
| 10888857327054 | Screw, Self-Tapping, Size Ø4.75x26 mm |
| 10888857327047 | Screw, Self-Tapping, Size Ø4.75x24 mm |
| 10888857327030 | Screw, Self-Tapping, Size Ø4.5x26 mm |
| 10888857327023 | Screw, Self-Tapping, Size Ø4.5x24 mm |
| 10888857320727 | Variable Drill Guide, Size Long |
| 10888857306899 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 26 mm |
| 10888857306882 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 24 mm |
| 10888857306875 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 22 mm |
| 10888857306868 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 20 mm |
| 10888857306851 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 18 mm |
| 10888857306844 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 16 mm |
| 10888857306837 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 14 mm |
| 10888857306820 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 12 mm |
| 10888857306813 | Self-Starting Screw, Constrained, Size Ø3.85 mm, 10 mm |
| 10888857306806 | Self-Starting Screw, Constrained, Size Ø3.5 mm, 26 mm |
| 10888857306790 | Self-Starting Screw, Constrained, Size Ø3.5 mm, 24 mm |
| 10888857306783 | Self-Starting Screw, Constrained, Size Ø3.5 mm, 22 mm |
| 10888857306776 | Self-Starting Screw, Constrained, Size Ø3.5 mm, 20 mm |
| 10888857303997 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 9 mm |
| 10888857303980 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 8 mm |
| 10888857303973 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 7 mm |
| 10888857303966 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 6 mm |
| 10888857303959 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 5 mm |
| 10888857303942 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 15 mm |
| 10888857303935 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 14 mm |
| 10888857303928 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 13 mm |
| 10888857303911 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 12 mm |
| 10888857303904 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 11 mm |
| 10888857303898 | Single Level Plate, 4 Screw, Size Ø4.0 mm, 10 mm |
| 10888857303881 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 9 mm |
| 10888857303874 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 8 mm |
| 10888857303867 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 7 mm |
| 10888857303850 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 6 mm |
| 10888857303843 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 5 mm |
| 10888857303836 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 15 mm |
| 10888857303829 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 14 mm |
| 10888857303812 | Single Level Plate, 3 Screw, Size Ø4.0 mm, 13 mm |
Trademark Results [PYRENEES]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PYRENEES 87594181 not registered Live/Pending |
The Burchell Nursery, Inc. 2017-09-01 |
 PYRENEES 85076209 not registered Dead/Abandoned |
Pyrenees Vineyard and Cellars, LLC 2010-07-01 |
 PYRENEES 78491726 3325782 Live/Registered |
K2M, INC. 2004-09-29 |
 PYRENEES 73504670 1354302 Dead/Cancelled |
KOL INCORPORATED 1984-10-19 |
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