DENALI® MI Spinal System 1001-E5550-SG
GUDID 10888857002029
Contoured Rod, Bulleted Hex, Size Ø5.5x50 mm, Ti
K2M, INC.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 10888857002029 |
| NIH Device Record Key | dee7229d-edd2-4742-8563-131da145e589 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENALI® MI Spinal System |
| Version Model Number | 1001-E5550-SG |
| Catalog Number | 1001-E5550-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 |
Device Dimensions
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857002029 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141873
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
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 [DENALI® MI Spinal System]
| 10888857421004 | Contoured Rod, Bulleted Hex, Size Ø5.5x120 mm, Ti |
| 10888857420991 | Contoured Rod, Bulleted Hex, Size Ø5.5x115 mm, Ti |
| 10888857419810 | Straight Rod, Bulleted Hex, Size Ø5.5x500 mm, Ti |
| 10888857418684 | Straight Rod, Bulleted Hex, Size Ø5.5x275 mm, Ti |
| 10888857418677 | Straight Rod, Bulleted Hex, Size Ø5.5x225 mm, Ti |
| 10888857418660 | Straight Rod, Bulleted Hex, Size Ø5.5x175 mm, Ti |
| 10888857418653 | Straight Rod, Bulleted Hex, Size Ø5.5x300 mm, Ti |
| 10888857418646 | Straight Rod, Bulleted Hex, Size Ø5.5x290 mm, Ti |
| 10888857418639 | Straight Rod, Bulleted Hex, Size Ø5.5x280 mm, Ti |
| 10888857418622 | Straight Rod, Bulleted Hex, Size Ø5.5x270 mm, Ti |
| 10888857418615 | Straight Rod, Bulleted Hex, Size Ø5.5x260 mm, Ti |
| 10888857418608 | Straight Rod, Bulleted Hex, Size Ø5.5x250 mm, Ti |
| 10888857418592 | Straight Rod, Bulleted Hex, Size Ø5.5x240 mm, Ti |
| 10888857418585 | Straight Rod, Bulleted Hex, Size Ø5.5x230 mm, Ti |
| 10888857418578 | Straight Rod, Bulleted Hex, Size Ø5.5x220 mm, Ti |
| 10888857418561 | Straight Rod, Bulleted Hex, Size Ø5.5x210 mm, Ti |
| 10888857418554 | Straight Rod, Bulleted Hex, Size Ø5.5x190 mm, Ti |
| 10888857418547 | Straight Rod, Bulleted Hex, Size Ø5.5x180 mm, Ti |
| 10888857418530 | Straight Rod, Bulleted Hex, Size Ø5.5x170 mm, Ti |
| 10888857418523 | Straight Rod, Bulleted Hex, Size Ø5.5x160 mm, Ti |
| 10888857418516 | Straight Rod, Bulleted Hex, Size Ø5.5x200 mm, Ti |
| 10888857418141 | Straight Rod, Bulleted Hex, Size Ø5.5x140 mm, Ti |
| 10888857418134 | Straight Rod, Bulleted Hex, Size Ø5.5x130 mm, Ti |
| 10888857418127 | Straight Rod, Bulleted Hex, Size Ø5.5x150 mm, Ti |
| 10888857417861 | Contoured Rod, Bulleted Hex, Size Ø5.5x150 mm, Ti |
| 10888857417847 | Contoured Rod, Bulleted Hex, Size Ø5.5x140 mm, Ti |
| 10888857417823 | Contoured Rod, Bulleted Hex, Size Ø5.5x130 mm, Ti |
| 10888857183292 | Polyaxial Screw, Cannulated, Size Ø4.5x35 mm |
| 10888857183285 | Polyaxial Screw, Cannulated, Size Ø4.5x30 mm |
| 10888857183278 | Polyaxial Screw, Cannulated, Size Ø4.5x25 mm |
| 10888857148680 | Monoaxial Screw, Cannulated, Size Ø8.5x95 mm |
| 10888857148673 | Monoaxial Screw, Cannulated, Size Ø8.5x90 mm |
| 10888857148666 | Monoaxial Screw, Cannulated, Size Ø8.5x85 mm |
| 10888857148659 | Monoaxial Screw, Cannulated, Size Ø8.5x80 mm |
| 10888857148642 | Monoaxial Screw, Cannulated, Size Ø8.5x75 mm |
| 10888857148635 | Monoaxial Screw, Cannulated, Size Ø8.5x70 mm |
| 10888857148628 | Monoaxial Screw, Cannulated, Size Ø8.5x65 mm |
| 10888857148611 | Monoaxial Screw, Cannulated, Size Ø8.5x60 mm |
| 10888857148604 | Monoaxial Screw, Cannulated, Size Ø8.5x55 mm |
| 10888857148598 | Monoaxial Screw, Cannulated, Size Ø8.5x50 mm |
| 10888857148581 | Monoaxial Screw, Cannulated, Size Ø8.5x45 mm |
| 10888857148574 | Monoaxial Screw, Cannulated, Size Ø8.5x40 mm |
| 10888857148567 | Monoaxial Screw, Cannulated, Size Ø8.5x35 mm |
| 10888857148550 | Monoaxial Screw, Cannulated, Size Ø8.5x30 mm |
| 10888857148543 | Monoaxial Screw, Cannulated, Size Ø8.5x25 mm |
| 10888857148536 | Monoaxial Screw, Cannulated, Size Ø8.5x110 mm |
| 10888857148529 | Monoaxial Screw, Cannulated, Size Ø8.5x105 mm |
| 10888857148512 | Monoaxial Screw, Cannulated, Size Ø8.5x100 mm |
| 10888857148505 | Monoaxial Screw, Cannulated, Size Ø7.5x95 mm |
| 10888857148499 | Monoaxial Screw, Cannulated, Size Ø7.5x90 mm |
Trademark Results [DENALI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DENALI 98685102 not registered Live/Pending |
DENALI BRANDS, LLC 2024-08-06 |
 DENALI 98685100 not registered Live/Pending |
DENALI BRANDS, LLC 2024-08-06 |
 DENALI 98642977 not registered Live/Pending |
Holloway, Kerith 2024-07-11 |
 DENALI 98619126 not registered Live/Pending |
GP IMPORTS COMERCIO DE PECAS E ACESSORIOS PARA VEICULOS LTDA 2024-06-26 |
 DENALI 98408434 not registered Live/Pending |
Diamond D Outdoors, LLC 2024-02-16 |
 DENALI 98336056 not registered Live/Pending |
Perks and Re-creation Disc Golf LLC 2023-12-29 |
 DENALI 97720727 not registered Live/Pending |
Valmont Industries, Inc. 2022-12-16 |
 DENALI 97646291 not registered Live/Pending |
True Temper Sports, Inc. 2022-10-25 |
 DENALI 97522669 not registered Live/Pending |
S. Rays, Inc. 2022-07-27 |
 DENALI 97463534 not registered Live/Pending |
Denali Water Solutions LLC 2022-06-17 |
 DENALI 97463531 not registered Live/Pending |
Denali Water Solutions LLC 2022-06-17 |
 DENALI 97463528 not registered Live/Pending |
Denali Water Solutions LLC 2022-06-17 |
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