PYRENEES® Cervical Plate Syst 201-14020C
GUDID 10888857027107
Self-Tapping Screw, Constrained
K2M, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10888857027107 |
| NIH Device Record Key | 9e17bbf5-0ddf-4e0d-85cf-2cd725e674d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRENEES® Cervical Plate Syst |
| Version Model Number | 201-14020C |
| Catalog Number | 201-14020C |
| 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 |
| 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 | |
| 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 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857027107 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063544
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
Moist Heat or Steam Sterilization
[10888857027107]
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 | 2015-10-24 |
Devices Manufactured by K2M, INC.
| 10888857525801 - CASCADIA™ Interbody System | 2024-11-12 AN Inserter Inner Shaft |
| 10888857525818 - CASCADIA™ Interbody System | 2024-11-12 AN Lordotic - Oblique Inserter Size 10 mm |
| 10888857006072 - DENALI® Spinal System | 2024-11-06 Straight Rod Size Ø5.5x110 mm Ti |
| 10888857006256 - DENALI® Spinal System | 2024-11-06 Straight Rod Size Ø5.5x45 mm Ti |
| 10888857006324 - DENALI® Spinal System | 2024-11-06 Straight Rod Size Ø5.5x55 mm Ti |
| 10888857006362 - DENALI® Spinal System | 2024-11-06 Straight Rod Size Ø5.5x65 mm Ti |
| 10888857006409 - DENALI® Spinal System | 2024-11-06 Straight Rod Size Ø5.5x75 mm Ti |
| 10888857006447 - DENALI® Spinal System | 2024-11-06 Straight Rod Size Ø5.5x85 mm Ti |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.