| Primary Device ID | 10888857421776 |
| NIH Device Record Key | a8cde98c-4cb1-47a8-bac1-f4e32afdf139 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVEREST Spinal System |
| Version Model Number | 2901-90241 |
| Catalog Number | 2901-90241 |
| Company DUNS | 146060863 |
| Company Name | K2M, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857421776 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
[10888857421776]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-15 |
| Device Publish Date | 2022-08-06 |
| 10888857469631 | Transverse Coupler, Size Ø17.3 |
| 10888857469624 | Transverse Coupler, Size Ø16.1 |
| 10888857469617 | Transverse Coupler, Size Ø14.4 |
| 10888857484900 | Straight Lumbar Probe |
| 10888857550742 | Ball Tip Feeler |
| 10888857551114 | Cannulated Probe |
| 10888857551084 | Adjustable Hook Housing |
| 10888857551077 | Angled Hook (Right) |
| 10888857551060 | Angled Hook (Left) |
| 10888857551053 | Hook |
| 10888857551862 | Parallel Distractor |
| 10888857551855 | Parallel Compressor |
| 10888857042186 | Polyaxial Screw Size Ø6.0x95 mm |
| 10888857042179 | Polyaxial Screw Size Ø6.0x90 mm |
| 10888857042162 | Polyaxial Screw Size Ø6.0x85 mm |
| 10888857042155 | Polyaxial Screw Size Ø6.0x80 mm |
| 10888857042148 | Polyaxial Screw Size Ø6.0x75 mm |
| 10888857042131 | Polyaxial Screw Size Ø6.0x70 mm |
| 10888857042117 | Polyaxial Screw Size Ø6.0x60 mm |
| 10888857042100 | Polyaxial Screw Size Ø6.0x55 mm |
| 10888857042094 | Polyaxial Screw Size Ø6.0x50 mm |
| 10888857042087 | Polyaxial Screw Size Ø6.0x45 mm |
| 10888857042070 | Polyaxial Screw Size Ø6.0x40 mm |
| 10888857042063 | Polyaxial Screw Size Ø6.0x35 mm |
| 10888857042056 | Polyaxial Screw Size Ø6.0x30 mm |
| 10888857042049 | Polyaxial Screw Size Ø6.0x25 mm |
| 10888857042032 | Polyaxial Screw Size Ø6.0x110 mm |
| 10888857042025 | Polyaxial Screw Size Ø6.0x105 mm |
| 10888857042018 | Polyaxial Screw Size Ø6.0x100 mm |
| 10888857550711 | Quick Connect Adapter |
| 10888857384415 | French Rod Bender Ø5.5-6.0 mm |
| 10888857551992 | Compressor |
| 10888857551985 | Anti Torque Handle |
| 10888857552104 | Curved Thoracic Probe Size 288 mm |
| 10888857552098 | Curved Thoracic Probe Size 238 mm |
| 10888857552081 | Straight Thoracic Probe Size 288 mm |
| 10888857552074 | Straight Thoracic Probe Size 238 mm |
| 10888857433960 | MI Rod Inserter |
| 10888857348035 | Driver, Height Adjustment Size 25 (Long) |
| 10888857348028 | Driver, Height Adjustment Size 25 (Short) |
| 10888857555754 | T-handle |
| 10888857454774 | Guidewire Holder |
| 10888857383395 | Screw Head Adjuster |
| 10888857555877 | Curved Thoracic Probe |
| 10888857555860 | Straight Thoracic Probe |
| 10888857553811 | Tapered Driver, Hex Size 30 |
| 10888857472372 | Deformity Rod Reducer |
| 10888857423541 | Final Shear Driver |
| 10888857421813 | Shear Set Screw Ejector |
| 10888857421776 | Anti-Torque Alignment Tube Shear Set Screw (Short) |