MESA® Spinal System 801-07545-SG
GUDID 10888857136878
Polyaxial Screw, Size Ø7.5x45 mm
K2M, INC.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 10888857136878 |
| NIH Device Record Key | 0b6fe201-7307-411b-a601-dcc764de18e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MESA® Spinal System |
| Version Model Number | 801-07545-SG |
| Catalog Number | 801-07545-SG |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | |
| 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 | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 45 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857136878 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141873
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-14 |
On-Brand Devices [MESA® Spinal System]
| 10888857420489 | Dual Transition Rail Size Ø5.5x500, 200 mm |
| 10888857420410 | MESA Rail™ Deformity Contoured, Size 495 mm Ti |
| 10888857420403 | MESA Rail™ Deformity Contoured, Size 375 mm Ti |
| 10888857420373 | Dual Transition Rail Size Ø5.5x500, 150 mm |
| 10888857420366 | Dual Transition Rail Size Ø5.5x500, 100 mm |
| 10888857420229 | Transition Rail, Size Ø5.5x495 mm, CoCr, MESA Rail™ |
| 10888857420212 | Straight Rail, Size Ø5.5x495 mm CoCr MESA Rail™ |
| 10888857420182 | Transition Rail Size Ø5.5x495 mm Ti |
| 10888857420175 | Straight Rail™ Size Ø5.5x495 mm Ti |
| 10888857368927 | Contoured Transition MESA Rail™, Size 350 mm |
| 10888857368910 | Contoured Transition MESA Rail™, Size 350 mm |
| 10888857368903 | Contoured Transition MESA Rail™, Size 500 mm |
| 10888857368897 | Contoured Transition MESA Rail™, Size 325 mm |
| 10888857368880 | Contoured Transition MESA Rail™, Size 600 mm |
| 10888857368873 | Contoured Transition MESA Rail™, Size 495 mm |
| 10888857368866 | Contoured Transition MESA Rail™, Size 375 mm |
| 10888857368859 | Contoured Transition MESA Rail™, Size 300 mm |
| 10888857368842 | Contoured Transition MESA Rail™, Size 250 mm |
| 10888857368835 | Contoured Transition MESA Rail™, Size 500 mm |
| 10888857368828 | Contoured Transition MESA Rail™, Size 325 mm |
| 10888857368811 | Contoured Transition MESA Rail™, Size 600 mm |
| 10888857368804 | Contoured Transition MESA Rail™, Size 495 mm |
| 10888857368798 | Contoured Transition MESA Rail™, Size 375 mm |
| 10888857368781 | Contoured Transition MESA Rail™, Size 300 mm |
| 10888857368774 | Contoured Transition MESA Rail™, Size 250 mm |
| 10888857314252 | MESA Rail™ Deformity Contoured, Size 350 mm CoCr |
| 10888857314245 | MESA Rail™ Deformity Contoured, Size 350 mm Ti |
| 10888857314238 | MESA Rail™ Deformity Contoured, Size 600 mm CoCr |
| 10888857314221 | MESA Rail™ Deformity Contoured, Size 300 mm CoCr |
| 10888857314214 | MESA Rail™ Deformity Contoured, Size 600 mm Ti |
| 10888857314207 | MESA Rail™ Deformity Contoured, Size 300 mm Ti |
| 10888857310377 | MESA Rail™ Deformity Contoured, Size 325 mm Ti |
| 10888857310360 | MESA Rail™ Deformity Contoured, Size 325 mm CoCr |
| 10888857304581 | Dual Transition Rail (Rod), Size Ø5.5x600, 75 mm |
| 10888857304574 | Dual Transition Rail (Rod), Size Ø5.5x600, 50 mm |
| 10888857304567 | Dual Transition Rail (Rod), Size Ø5.5x600, 350 mm |
| 10888857304550 | Dual Transition Rail (Rod), Size Ø5.5x600, 325 mm |
| 10888857304543 | Dual Transition Rail (Rod), Size Ø5.5x600, 300 mm |
| 10888857304536 | Dual Transition Rail (Rod), Size Ø5.5x600, 275 mm |
| 10888857304529 | Dual Transition Rail (Rod), Size Ø5.5x600, 250 mm |
| 10888857304512 | Dual Transition Rail (Rod), Size Ø5.5x600, 225 mm |
| 10888857304505 | Dual Transition Rail (Rod), Size Ø5.5x600, 200 mm |
| 10888857304499 | Dual Transition Rail (Rod), Size Ø5.5x600, 175 mm |
| 10888857304482 | Dual Transition Rail (Rod), Size Ø5.5x600, 150 mm |
| 10888857304475 | Dual Transition Rail (Rod), Size Ø5.5x600, 125 mm |
| 10888857304468 | Dual Transition Rail (Rod), Size Ø5.5x600, 100 mm |
| 10888857304451 | Dual Transition Rail (Rod), Size Ø5.5x500, 75 mm |
| 10888857304444 | Dual Transition Rail (Rod), Size Ø5.5x500, 50 mm |
| 10888857304437 | Dual Transition Rail (Rod), Size Ø5.5x500, 350 mm |
| 10888857304420 | Dual Transition Rail (Rod), Size Ø5.5x500, 325 mm |
Trademark Results [MESA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MESA 98825271 not registered Live/Pending |
Nam, James 2024-10-29 |
 MESA 98492708 not registered Live/Pending |
Holley Performance Products Inc. 2024-04-10 |
 MESA 98445298 not registered Live/Pending |
LaylaTex Holdings, Inc. 2024-03-12 |
 MESA 98436220 not registered Live/Pending |
Strong Industries, Inc. 2024-03-06 |
 MESA 97789924 not registered Live/Pending |
PROFFITT BROTHERS INVESTMENTS LLC 2023-02-10 |
 MESA 97789909 not registered Live/Pending |
PROFFITT BROTHERS INVESTMENTS LLC 2023-02-10 |
 MESA 97594646 not registered Live/Pending |
Solo Brands, LLC 2022-09-16 |
 MESA 97556580 not registered Live/Pending |
Boxgear International LLC 2022-08-19 |
 MESA 97414185 not registered Live/Pending |
Monument Grill LLC 2022-05-17 |
 MESA 97382595 not registered Live/Pending |
Wheel Pros, LLC 2022-04-26 |
 MESA 90749152 not registered Live/Pending |
MESA CARRIERS, LLC 2021-06-02 |
 MESA 90691906 not registered Live/Pending |
Sidewalk Labs LLC 2021-05-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.