DENALI® Spinal System 101-B55200H-G1
GUDID 10888857419452
Straight Def. Rod, Dual Hex Stop, Size Ø5.5x200 mm, Ti
K2M, INC.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 10888857419452 |
| NIH Device Record Key | a33229cc-e75b-4b60-9459-0c2697b49ac0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENALI® Spinal System |
| Version Model Number | 101-B55200H-G1 |
| Catalog Number | 101-B55200H-G1 |
| 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 | 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 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@k2m.com | |
| Phone | +1(703)777-3155 |
| ngiezen@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 |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 200 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857419452 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-21 |
| Device Publish Date | 2018-12-19 |
On-Brand Devices [DENALI® Spinal System]
| 10888857421028 | Straight Deformity Rod, Hex, Size Ø5.5x120 mm, Ti |
| 10888857421011 | Straight Rod, Size Ø5.5x120 mm Ti |
| 10888857420519 | Straight Deformity Rod, Dual Hex, Size Ø5.5x600 mm, CoCr |
| 10888857420502 | Straight Deformity Rod, Hex, Size Ø5.5x600 mm, CP4 |
| 10888857420496 | Straight Deformity Rod, Hex, Size Ø5.5x600 mm, Ti |
| 10888857420069 | Straight Deformity Rod, Dual Hex, Size Ø5.5x500 mm CoCr |
| 10888857420052 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x500 mm, CoCr |
| 10888857420045 | Straight Deformity Rod, Dual Hex, Size Ø5.5x400 mm, CoCr |
| 10888857420038 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x400 mm, CoCr |
| 10888857420021 | Straight Deformity Rod, Hex, Size Ø5.5x500 mm, CoCr |
| 10888857420014 | Straight Deformity Rod, Hex, Size Ø5.5x400 mm, CoCr |
| 10888857419971 | Straight Deformity Rod, Hex, Size Ø5.5x500 mm CP3 |
| 10888857419964 | Straight Deformity Rod, Hex, Size Ø5.5x400 mm, CP3 |
| 10888857419957 | Straight Deformity Rod, Hex, Size Ø5.5x500 mm CP4 |
| 10888857419940 | Straight Deformity Rod, Hex, Size Ø5.5x400 mm, CP4 |
| 10888857419933 | Straight Deformity Rod, Dual Hex, Size Ø5.5x500 mm, Ti |
| 10888857419926 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x500 mm, Ti |
| 10888857419919 | Straight Deformity Rod, Dual Hex, Size Ø5.5x400 mm, Ti |
| 10888857419902 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x400 mm, Ti |
| 10888857419896 | Straight Deformity Rod, Hex, Size Ø5.5x500 mm Ti |
| 10888857419889 | Straight Deformity Rod, Hex, Size Ø5.5x400 mm, Ti |
| 10888857419872 | Straight Rod, Size Ø5.5x500 mm, Ti |
| 10888857419865 | Straight Rod, Size Ø5.5x400 mm, Ti |
| 10888857419629 | Straight Deformity Rod, Dual Hex, Size Ø5.5x300 mm, CoCr |
| 10888857419612 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x300 mm, CoCr |
| 10888857419605 | Straight Deformity Rod, Dual Hex, Size Ø5.5x200 mm, CoCr |
| 10888857419599 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x200 mm, CoCr |
| 10888857419582 | Straight Deformity Rod, Hex, Size Ø5.5x300 mm, CoCr |
| 10888857419575 | Straight Deformity Rod, Hex, Size Ø5.5x200 mm, CoCr |
| 10888857419520 | Straight Deformity Rod, Hex, Size Ø5.5x300 mm, CP3 |
| 10888857419513 | Straight Deformity Rod, Hex, Size Ø5.5x200 mm, CP3 |
| 10888857419506 | Straight Deformity Rod, Hex, Size Ø5.5x300 mm, CP4 |
| 10888857419490 | Straight Deformity Rod, Hex, Size Ø5.5x200 mm, CP4 |
| 10888857419483 | Straight Deformity Rod, Dual Hex, Size Ø5.5x300 mm, Ti |
| 10888857419476 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x300 mm, Ti |
| 10888857419469 | Straight Deformity Rod, Dual Hex, Size Ø5.5x200 mm, Ti |
| 10888857419452 | Straight Def. Rod, Dual Hex Stop, Size Ø5.5x200 mm, Ti |
| 10888857419445 | Straight Deformity Rod, Hex, Size Ø5.5x300 mm, Ti |
| 10888857419438 | Straight Deformity Rod, Hex, Size Ø5.5x200 mm, Ti |
| 10888857419421 | Straight Rod, Size Ø5.5x300 mm, Ti |
| 10888857419414 | Straight Rod, Size Ø5.5x200 mm Ti |
| 10888857418493 | Offset Rod, Size Ø5.5x300 mm, CoCr |
| 10888857418486 | Offset Rod, Size Ø5.5x300 mm, Ti |
| 10888857417977 | Contoured Rod, Size Ø5.5x150 mm, CoCr |
| 10888857417960 | Contoured Rod, Size Ø5.5x125 mm, CoCr |
| 10888857417953 | Straight Rod, Size Ø5.5x140 mm, Ti |
| 10888857417946 | Straight Rod, Size Ø5.5x130 mm, Ti |
| 10888857417915 | Straight Deformity Rod, Dual Hex, Size Ø5.5x150 mm, Ti |
| 10888857417908 | Straight Deformity Rod, Hex, Size Ø5.5x150 mm, Ti |
| 10888857417892 | Straight Rod, Size Ø5.5x150 mm Ti |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.