MESA® Small Stature Spinal System 3001-75550HC-D15
GUDID 10888857051751
Lateral Offset Connector, Closed
K2M, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10888857051751 |
| NIH Device Record Key | 1947be9f-2bf6-4c17-afbc-68b13316d52b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MESA® Small Stature Spinal System |
| Version Model Number | 3001-75550HC-D15 |
| Catalog Number | 3001-75550HC-D15 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857051751 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123412
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
Moist Heat or Steam Sterilization
[10888857051751]
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 [MESA® Small Stature Spinal System]
| 10888857421035 | Straight Deformity Rod, Dual Hex, Size Ø4.5x100 mm Ti |
| 10888857420830 | Straight Rail, Size Ø4.5x500 mm Ti, MESA Rail™ |
| 10888857420823 | Contoured Rod, Size Ø4.5x95 mm, Ti |
| 10888857420816 | Contoured Rod, Size Ø4.5x50 mm, Ti |
| 10888857420809 | Contoured Rod, Size Ø4.5x40 mm, Ti |
| 10888857420793 | Contoured Rod, Size Ø4.5x35 mm, Ti |
| 10888857420786 | Contoured Rod, Size Ø4.5x30 mm, Ti |
| 10888857420342 | MESA Rail™ Deformity Contoured, Size 500 mm CoCr |
| 10888857420335 | MESA Rail™ Deformity Contoured, Size 375 mm CoCr |
| 10888857420328 | Transition Rail, Size Ø4.5x500 mm, CoCr, MESA Rail™ |
| 10888857420311 | Straight Rail, Size Ø4.5x500 mm CoCr, MESA Rail™ |
| 10888857420304 | MESA Rail™ Deformity Contoured, Size 500 mm Ti |
| 10888857420298 | MESA Rail™ Deformity Contoured, Size 300 mm Ti |
| 10888857420281 | Transition Rail, Size Ø4.5x500 mm, Ti, MESA Rail™ |
| 10888857420274 | Straight Rail, Size Ø4.5x500 mm Ti, MESA Rail™ |
| 10888857420144 | Straight Deformity Rod, Dual Hex, Size Ø4.5x500 mm CoCr |
| 10888857420120 | Transition Rod, Size Ø4.5/Ø5.5x500 mm CoCr |
| 10888857420106 | Straight Deformity Rod, Dual Hex, Size Ø4.5x500 mm Ti |
| 10888857420083 | Transition Rod, Size Ø4.5/Ø5.5x500 mm Ti |
| 10888857419704 | Straight Deformity Rod, Dual Hex, Size Ø4.5x300 mm CoCr |
| 10888857419667 | Straight Deformity Rod, Dual Hex, Size Ø4.5x300 mm Ti |
| 10888857418080 | Contoured, Size Ø4.5x150 mm, CoCr, MESA Rail™ |
| 10888857418073 | Contoured Rod, Size Ø4.5x150 mm, CoCr |
| 10888857418066 | Contoured Rod, Size Ø4.5x125 mm, CoCr |
| 10888857418059 | Contoured Rod, Size Ø4.5x150 mm, Ti |
| 10888857418042 | Contoured Rod, Size Ø4.5x125 mm, Ti |
| 10888857417939 | Straight Deformity Rod, Dual Hex, Size Ø4.5x150 mm CoCr |
| 10888857417922 | Straight Deformity Rod, Dual Hex, Size Ø4.5x150 mm Ti |
| 10888857411241 | Straight Rail, Size Ø4.5x70 mm CoCr, MESA Rail™ |
| 10888857411234 | Straight Rail, Size Ø4.5x60 mm CoCr, MESA Rail™ |
| 10888857411227 | Straight Rail, Size Ø4.5x50 mm CoCr, MESA Rail™ |
| 10888857411210 | Straight Rail, Size Ø4.5x40 mm CoCr, MESA Rail™ |
| 10888857411203 | Contoured Rod, Size Ø4.5x95 mm, CoCr |
| 10888857411197 | Contoured Rod, Size Ø4.5x90 mm, CoCr |
| 10888857411180 | Contoured Rod, Size Ø4.5x85 mm, CoCr |
| 10888857411173 | Contoured Rod, Size Ø4.5x80 mm, CoCr |
| 10888857411166 | Contoured Rod, Size Ø4.5x75 mm, CoCr |
| 10888857411159 | Contoured Rod, Size Ø4.5x70 mm, CoCr |
| 10888857411142 | Contoured Rod, Size Ø4.5x65 mm, CoCr |
| 10888857411135 | Contoured Rod, Size Ø4.5x60 mm, CoCr |
| 10888857411128 | Contoured Rod, Size Ø4.5x55 mm, CoCr |
| 10888857411111 | Contoured Rod, Size Ø4.5x50 mm, CoCr |
| 10888857411104 | Contoured Rod, Size Ø4.5x45 mm, CoCr |
| 10888857411098 | Contoured Rod, Size Ø4.5x40 mm, CoCr |
| 10888857411081 | Contoured Rod, Size Ø4.5x35 mm, CoCr |
| 10888857411074 | Contoured Rod, Size Ø4.5x30 mm, CoCr |
| 10888857411067 | Contoured Rod, Size Ø4.5x110 mm, CoCr |
| 10888857411050 | Contoured Rod, Size Ø4.5x100 mm, CoCr |
| 10888857411043 | Straight Rail, Size Ø4.5x500 mm Ti, MESA Rail™ |
| 10888857411036 | Straight Rail, Size Ø4.5x500 mm Ti, MESA Rail™ |
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.