ALEUTIAN® Interbody Systems 3303-21628ML5
GUDID 10888857074811
TLIF II Implant, Size 10x28x16 mm, 5°
K2M, INC.
Vertebral body prosthesis, non-sterile| Primary Device ID | 10888857074811 |
| NIH Device Record Key | b1566ab5-4c66-49b2-87ee-91ac10e6f4bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALEUTIAN® Interbody Systems |
| Version Model Number | 3303-21628ML5 |
| Catalog Number | 3303-21628ML5 |
| 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 |
| 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 |
Device Dimensions
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
| Angle | 5 degree |
| Length | 28 Millimeter |
| Height | 16 Millimeter |
| Width | 10 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857074811 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110843
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
Moist Heat or Steam Sterilization
[10888857074811]
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 | 2017-05-19 |
On-Brand Devices [ALEUTIAN® Interbody Systems]
| 10888857430914 | Cervical Inserter, Size 16 mm |
| 10888857430907 | Cervical Inserter, Size 14 mm |
| 10888857429734 | Angled Lateral Inserter, 40° |
| 10888857421080 | Angled Lateral Inserter, 25° |
| 10888857415959 | Trial, Size 0 |
| 10888857399136 | Lateral Inserter Inner Shaft |
| 10888857388659 | Horseshoe, Threaded Inserter, |
| 10888857381506 | Cervical Inserter |
| 10888857352711 | Cervical Inserter, Size 16 mm |
| 10888857347311 | Inserter, Large Handle |
| 10888857328747 | Inserter, Size 11x14 mm |
| 10888857328679 | Inserter, Size 11x11 mm |
| 10888857308084 | Parallel Rasp, Size 18x45x19 mm |
| 10888857308077 | Parallel Rasp, Size 18x45x18 mm |
| 10888857308060 | Parallel Rasp, Size 18x45x17 mm |
| 10888857308053 | Parallel Rasp, Size 18x45x16 mm |
| 10888857308046 | Parallel Rasp, Size 18x45x15 mm |
| 10888857308039 | Parallel Rasp, Size 18x45x14 mm |
| 10888857308022 | Parallel Rasp, Size 18x45x13 mm |
| 10888857308015 | Parallel Rasp, Size 18x45x12 mm |
| 10888857308008 | Parallel Rasp, Size 18x45x11 mm |
| 10888857307995 | Parallel Rasp, Size 18x45x10 mm |
| 10888857307988 | Parallel Rasp, Size 18x45x9 mm |
| 10888857307971 | Parallel Rasp, Size 18x45x8 mm |
| 10888857307964 | Parallel Rasp, Size 18x45x7 mm |
| 10888857307957 | Parallel Rasp, Size 18x45x6 mm |
| 10888857251144 | Lateral Inserter |
| 10888857250970 | Lateral Inserter |
| 10888857250321 | Convex Trial, Size 17x12x32 mm |
| 10888857250314 | Convex Trial, Size 15x12x32 mm |
| 10888857250307 | Convex Trial, Size 14x12x32 mm |
| 10888857250291 | Convex Trial, Size 13x12x32 mm |
| 10888857250284 | Convex Trial, Size 12x12x32 mm |
| 10888857250277 | Convex Trial, Size 11x12x32 mm |
| 10888857250260 | Convex Trial, Size 10x12x32 mm |
| 10888857250253 | Convex Trial, Size 9x12x32 mm |
| 10888857250246 | Convex Trial, Size 8x12x32 mm |
| 10888857250239 | Convex Trial, Size 7x12x32 mm |
| 10888857250222 | Convex Trial, Size 6x12x32 mm |
| 10888857250215 | Convex Trial, Size 5x12x32 mm |
| 10888857184589 | Lordotic Trial, Size 28x36x21 mm, 10° |
| 10888857184572 | Lordotic Trial, Size 28x36x19 mm, 10° |
| 10888857184565 | Lordotic Trial, Size 28x36x17 mm, 10° |
| 10888857184558 | Lordotic Trial, Size 28x36x15 mm, 10° |
| 10888857184541 | Lordotic Trial, Size 28x36x13 mm, 10° |
| 10888857184534 | Lordotic Trial, Size 28x36x11 mm, 10° |
| 10888857184527 | Lordotic Trial, Size 28x36x9 mm, 10° |
| 10888857184510 | Lordotic Trial, Size 24x30x21 mm, 10° |
| 10888857184503 | Lordotic Trial, Size 24x30x19 mm, 10° |
| 10888857184497 | Lordotic Trial, Size 24x30x17 mm, 10° |
Trademark Results [ALEUTIAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALEUTIAN 78725838 3266231 Live/Registered |
K2M, INC. 2005-10-04 |
 ALEUTIAN 77702580 not registered Dead/Abandoned |
Kohler Co. 2009-03-30 |
 ALEUTIAN 76350223 2717143 Dead/Cancelled |
LOWE ALPINE UK LIMITED 2001-12-17 |
 ALEUTIAN 75870846 2556907 Live/Registered |
GRAND BANKS YACHTS, LTD. 1999-12-10 |
 ALEUTIAN 74666721 not registered Dead/Abandoned |
Lowe Alpine Systems, Inc. 1995-04-28 |
 ALEUTIAN 74639928 2002335 Dead/Cancelled |
FISHKING PROCESSORS, INC. 1995-02-24 |
 ALEUTIAN 72421794 0992217 Dead/Expired |
VITA FOOD PRODUCTS, INC. 1972-04-19 |
 ALEUTIAN 72309511 0872986 Dead/Expired |
CROTON WATCH CO., INC. 1968-10-14 |
 ALEUTIAN 72109270 0739052 Dead/Expired |
POPPER SHOE CORPORATION, THE 1960-11-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.