CASPIAN® Spinal System 1101-10003
GUDID 10888857015623
Occipital Anchor Size 11 mm
K2M, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10888857015623 |
| NIH Device Record Key | 98100b91-ec24-4062-9db3-6ba29e848fbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CASPIAN® Spinal System |
| Version Model Number | 1101-10003 |
| Catalog Number | 1101-10003 |
| 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 | |
| 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 | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
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| Length | 11 Millimeter |
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| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Length | 11 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857015623 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133288
FDA Product Code
| NKG | Orthosis, cervical pedicle screw spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
Moist Heat or Steam Sterilization
[10888857015623]
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 [CASPIAN® Spinal System]
| 10888857420113 | Transition Rod, Size Ø3.5/Ø4.5x500 mm CoCr |
| 10888857420076 | Transition Rod, Size Ø3.5/Ø4.5x500 mm Ti |
| 10888857419674 | Transition Rod, Size Ø3.5/Ø4.5x300 mm CoCr |
| 10888857419636 | Transition Rod, Size Ø3.5/Ø4.5x300 mm Ti |
| 10888857271623 | Occipital Anchor Size 5mm |
| 10888857271616 | Occipital Anchor Size 5mm |
| 10888857271609 | Occipital Anchor Size 5mm |
| 10888857271593 | Occipital Anchor Size 5mm |
| 10888857235854 | Contoured Rod Size Ø3.5x95 mm |
| 10888857235847 | Contoured Rod Size Ø3.5x100 mm |
| 10888857213128 | Occipital Anchor Long, Left Hand, Size Long, 11 mm, Left Hand |
| 10888857213111 | Occipital Anchor Long, Left Hand, Size Long, 7 mm, Left Hand |
| 10888857213104 | Occipital Anchor Short, Left Hand Size 11 mm |
| 10888857213098 | Occipital Anchor Short, Left Hand Size 7 mm |
| 10888857177727 | Contoured Rod Size Ø3.5x90 mm |
| 10888857177710 | Contoured Rod Size Ø3.5x85 mm |
| 10888857177703 | Contoured Rod Size Ø3.5x75 mm |
| 10888857177697 | Contoured Rod Size Ø3.5x70 mm |
| 10888857177680 | Contoured Rod Size Ø3.5x65 mm |
| 10888857177673 | Contoured Rod Size Ø3.5x60 mm |
| 10888857177666 | Contoured Rod Size Ø3.5x55 mm |
| 10888857177659 | Contoured Rod Size Ø3.5x50 mm |
| 10888857177642 | Contoured Rod Size Ø3.5x45 mm |
| 10888857177604 | Contoured Rod Size Ø3.5x115 mm |
| 10888857177598 | Contoured Rod Size Ø3.5x110 mm |
| 10888857177581 | Contoured Rod Size Ø3.5x105 mm |
| 10888857158054 | MESA®Mini Long Shank Screw Size Ø4.0x40 mm |
| 10888857158047 | MESA®Mini Long Shank Screw Size Ø4.0x38 mm |
| 10888857158030 | MESA®Mini Long Shank Screw Size Ø4.0x36 mm |
| 10888857158023 | MESA®Mini Long Shank Screw Size Ø4.0x34 mm |
| 10888857158016 | MESA®Mini Long Shank Screw Size Ø4.0x32 mm |
| 10888857158009 | MESA®Mini Long Shank Screw Size Ø4.0x30 mm |
| 10888857157996 | MESA®Mini Long Shank Screw Size Ø4.0x28 mm |
| 10888857157989 | MESA®Mini Long Shank Screw Size Ø4.0x26 mm |
| 10888857157972 | MESA®Mini Long Shank Screw, Modified, Size Ø4.0x24 mm, Modified |
| 10888857157965 | MESA®Mini Long Shank Screw, Modified, Size Ø4.0x22 mm, Modified |
| 10888857157958 | MESA®Mini Long Shank Screw, Modified, Size Ø4.0x20 mm, Modified |
| 10888857157941 | MESA®Mini Long Shank Screw, Modified, Size Ø4.0x18 mm, Modified |
| 10888857157934 | MESA®Mini Long Shank Screw, Modified, Size Ø4.0x16 mm, Modified |
| 10888857157927 | MESA®Mini Long Shank Screw Size Ø3.5x40 mm |
| 10888857157910 | MESA®Mini Long Shank Screw Size Ø3.5x38 mm |
| 10888857157903 | MESA®Mini Long Shank Screw Size Ø3.5x36 mm |
| 10888857157897 | MESA®Mini Long Shank Screw Size Ø3.5x34 mm |
| 10888857157880 | MESA®Mini Long Shank Screw Size Ø3.5x32 mm |
| 10888857157873 | MESA®Mini Long Shank Screw Size Ø3.5x30 mm |
| 10888857157866 | MESA®Mini Long Shank Screw Size Ø3.5x28 mm |
| 10888857157859 | MESA®Mini Long Shank Screw Size Ø3.5x26 mm |
| 10888857157842 | MESA®Mini Long Shank Screw, Modified |
| 10888857157835 | MESA®Mini Long Shank Screw, Modified, Size Ø3.5x22 mm, Modified |
| 10888857157828 | MESA®Mini Long Shank Screw, Modified, Size Ø3.5x20 mm, Modified |
Trademark Results [CASPIAN]
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