| Primary Device ID | 10888857429840 |
| NIH Device Record Key | b012f33e-8194-412a-a598-17762f946098 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K2M General Instruments |
| Version Model Number | AG01-96068 |
| Catalog Number | AG01-96068 |
| 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(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com | |
| Phone | +1(703)777-3155 |
| mark.zellers@stryker.com |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Width | 22 Millimeter |
| Height | 16 Millimeter |
| Angle | 8 degree |
| Length | 60 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857429840 [Primary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
[10888857429840]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-16 |
| Device Publish Date | 2020-04-08 |
| 10888857467521 | Lamina Spreader |
| 10888857466104 | Lamina Spreader |
| 10888857465763 | Offset Lamina Spreader |
| 10888857468306 | Spreader |
| 10888857463523 | Pusher, ALIF |
| 10888857463400 | Down Curette Bayoneted, Size #3 |
| 10888857463394 | Up Curette Bayoneted, Size #3 |
| 10888857463387 | Reverse Angled Curette Bayoneted, Size #3 |
| 10888857463370 | Right Angled Curette Bayoneted, Size #3 |
| 10888857463363 | Left Angled Curette Bayoneted, Size #3 |
| 10888857463356 | Left Facing Curette Bayoneted, Size #3 |
| 10888857463349 | Right Facing Curette Bayoneted, Size #3 |
| 10888857463332 | Down Serrated Curette Bayoneted, Size #3 |
| 10888857463325 | Up Serrated Curette Bayoneted, Size #3 |
| 10888857463318 | Angled Teardrop Curette Bayoneted, |
| 10888857463301 | Teardrop Curette Bayoneted |
| 10888857463295 | Angled Ring Curette Bayoneted |
| 10888857463288 | Ring Curette, Bayoneted |
| 10888857435445 | Integrated Graft Ramps, Size 22 mm |
| 10888857435438 | Integrated Graft Ramps, Size 18 mm |
| 10888857432406 | Lordotic Modular Trial, Size 22x60x16 mm, 12° |
| 10888857432390 | Lordotic Modular Trial, Size 22x60x14 mm, 12° |
| 10888857432383 | Lordotic Modular Trial, Size 22x60x12 mm, 12° |
| 10888857432376 | Lordotic Modular Trial, Size 22x60x10 mm, 12° |
| 10888857432369 | Silicone T-Handle with Strike Plate, |
| 10888857431058 | End Plate Rasp |
| 10888857429871 | Lordotic Modular Trial, Size 22x60x16 mm, 15° |
| 10888857429864 | Lordotic Modular Trial, Size 22x60x14 mm, 15° |
| 10888857429857 | Lordotic Modular Trial, Size 22x60x12 mm, 15° |
| 10888857429840 | Lordotic Modular Trial, Size 22x60x16 mm, 8° |
| 10888857429833 | Lordotic Modular Trial, Size 22x60x14 mm, 8° |
| 10888857429826 | Lordotic Modular Trial, Size 22x60x12 mm, 8° |
| 10888857429819 | Lordotic Modular Trial, Size 22x60x10 mm, 8° |
| 10888857429802 | Lordotic Modular Trial, Size 22x60x08 mm, 8° |
| 10888857429796 | Parallel Modular Trial, Size 22x60x16 mm, 0° |
| 10888857429789 | Parallel Modular Trial, Size 22x60x14 mm, 0° |
| 10888857429772 | Parallel Modular Trial, Size 22x60x12 mm, 0° |
| 10888857429765 | Parallel Modular Trial, Size 22x60x10 mm, 0° |
| 10888857429758 | Parallel Modular Trial, Size 22x60x08 mm, 0° |
| 10888857427747 | Angled Disc Wedge, Size 4-6 mm |
| 10888857427730 | Angled Disc Wedge, Size 3-5 mm |
| 10888857427723 | Disc Wedge, Size 4-6 mm |
| 10888857427716 | Disc Wedge, Size 3-5 mm |
| 10888857427709 | Stirrup Curette |
| 10888857423176 | 18 mm Lateral Box Chisel, Size 18x8 mm |
| 10888857423169 | 18 mm Lateral Box Chisel, Size 18x6 mm |
| 10888857423152 | 18 mm Lateral Box Chisel, Size 18x4 mm |
| 10888857423145 | Trial Rasp, Size 18x60x10 mm |
| 10888857423138 | Trial Rasp, Size 18x60x8 mm |
| 10888857423121 | Trial Rasp, Size 18x60x6 mm |