SANTORINI™ Corpectomy Cage System 1703-22414L
GUDID 10888857021082
PEEK Solid Cage
K2M, INC.
Vertebral body prosthesis, non-sterile| Primary Device ID | 10888857021082 |
| NIH Device Record Key | 6d8d3df4-cf45-4144-b1fc-b291a26f9f58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SANTORINI™ Corpectomy Cage System |
| Version Model Number | 1703-22414L |
| Catalog Number | 1703-22414L |
| 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 |
Device Dimensions
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
| Length | 12 Millimeter |
| Width | 14 Millimeter |
| Height | 24 Millimeter |
| Angle | 7 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857021082 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111294
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
Moist Heat or Steam Sterilization
[10888857021082]
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 [SANTORINI™ Corpectomy Cage System]
| 10888857323728 | Trial, Size 12x14-7°, 16-17 mm |
| 10888857323711 | Trial, Size 12x14-7°, 14-15 mm |
| 10888857323704 | Trial, Size 12x14-7°, 12-13 mm |
| 10888857243200 | Threaded Clip Inserter, Size 12x17 mm |
| 10888857243163 | Threaded Distractor, Size 12x17 mm |
| 10888857243101 | Cage Inserter, Size 12x14 mm |
| 10888857243095 | Cage Inserter, Size 12x17 mm |
| 10888857243088 | Footprint Trial, Size 12x17 mm |
| 10888857243071 | Footprint Trial, Size 12x14 mm |
| 10888857024939 | Expandable Cage |
| 10888857024922 | Expandable Cage |
| 10888857024915 | Expandable Cage |
| 10888857024908 | Expandable Cage |
| 10888857024892 | Expandable Cage |
| 10888857024823 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 114-122, 8° |
| 10888857024816 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 114-122, 4° |
| 10888857024809 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 114-122, 0° |
| 10888857024793 | Lateral Expandable Cage External |
| 10888857024786 | Lateral Expandable Cage External |
| 10888857024779 | Lateral Expandable Cage External |
| 10888857024731 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 106-114, 8° |
| 10888857024724 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 106-114, 4° |
| 10888857024717 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 106-114, 0° |
| 10888857024670 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 98-106, 8° |
| 10888857024663 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 98-106, 4° |
| 10888857024656 | Lateral Expandable Cage Internal, Size 21x25 mm Internal 98-106, 0° |
| 10888857024618 | Lateral Expandable Cage Internal |
| 10888857024601 | Lateral Expandable Cage Internal |
| 10888857024595 | Lateral Expandable Cage Internal |
| 10888857024557 | Lateral Expandable Cage Internal |
| 10888857024540 | Lateral Expandable Cage Internal |
| 10888857024533 | Lateral Expandable Cage Internal |
| 10888857024496 | Lateral Expandable Cage Internal |
| 10888857024489 | Lateral Expandable Cage Internal |
| 10888857024472 | Lateral Expandable Cage Internal |
| 10888857024434 | Lateral Expandable Cage Internal |
| 10888857024427 | Lateral Expandable Cage Internal |
| 10888857024410 | Lateral Expandable Cage Internal |
| 10888857024403 | Lateral Expandable Cage Internal, Size 16x20 mm Internal 66-74, 8° |
| 10888857024397 | Lateral Expandable Cage Internal, Size 16x20 mm Internal 66-74, 4° |
| 10888857024380 | Lateral Expandable Cage Internal, Size 16x20 mm Internal 66-74, 0° |
| 10888857024373 | Lateral Expandable Cage External |
| 10888857024366 | Lateral Expandable Cage External |
| 10888857024359 | Lateral Expandable Cage External |
| 10888857024311 | Lateral Expandable Cage Internal |
| 10888857024304 | Lateral Expandable Cage Internal |
| 10888857024298 | Lateral Expandable Cage Internal |
| 10888857024281 | Lateral Expandable Cage Internal, Size 16x20 mm Internal 58-66, 8° |
| 10888857024274 | Lateral Expandable Cage Internal, Size 16x20 mm Internal 58-66, 4° |
| 10888857024267 | Lateral Expandable Cage Internal, Size 16x20 mm Internal 58-66, 0° |
Trademark Results [SANTORINI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SANTORINI 98412231 not registered Live/Pending |
Stork Craft Manufacturing (USA) Inc. 2024-02-20 |
 SANTORINI 98157955 not registered Live/Pending |
Pradopark, S.A. 2023-08-30 |
 SANTORINI 90635504 not registered Live/Pending |
Sirob Imports, Inc. 2021-04-09 |
 SANTORINI 90460600 not registered Live/Pending |
Homesick BVG LLC 2021-01-12 |
 SANTORINI 88812566 not registered Live/Pending |
Michael Kors, L.L.C. 2020-02-27 |
 SANTORINI 88342161 5862825 Live/Registered |
SmartPool LLC 2019-03-15 |
 SANTORINI 87739390 not registered Dead/Abandoned |
Hesen, Alexander 2017-12-31 |
 SANTORINI 87079825 5274160 Live/Registered |
Jannoun, Saeb M 2016-06-22 |
 SANTORINI 86904897 5304244 Live/Registered |
BKBG Enterprises, Inc. 2016-02-11 |
 SANTORINI 86876662 not registered Dead/Abandoned |
saeb jannoun 2016-01-15 |
 SANTORINI 86350847 not registered Dead/Abandoned |
Konstantinos I. Katsiroumbas 2014-07-29 |
 SANTORINI 85857810 4450363 Live/Registered |
PYC Corp. 2013-02-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.