| Primary Device ID | 10888857556140 |
| NIH Device Record Key | e6bfd72e-316d-47e0-b111-02c5832c3f6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATP Disc Prep |
| Version Model Number | 8030-90044 |
| Catalog Number | 8030-90044 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857556140 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
[10888857556140]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-12 |
| Device Publish Date | 2024-01-04 |
| 10888857562905 | Instrument Tray |
| 10888857562899 | Instrument Tray |
| 10888857562882 | Instrument Tray |
| 10888857562875 | Instrument Tray |
| 10888857562868 | Instrument Tray |
| 10888857562851 | Instrument Tray |
| 10888857562844 | Instrument Tray |
| 10888857556355 | Orientation Indicator |
| 10888857556348 | Cobb, Left ATP, 50x22 mm |
| 10888857556331 | Cobb, Left ATP, 50x18 mm |
| 10888857556256 | Disc Wedge ATP, 4-6 mm |
| 10888857556249 | Disc Wedge ATP, 3-5 mm |
| 10888857556201 | Reverse Angled Curette ATP, #4 |
| 10888857556195 | Reverse Angled Curette ATP, #2 |
| 10888857556188 | Forward Angled Curette ATP, #4 |
| 10888857556171 | Forward Angled Curette ATP, #2 |
| 10888857556164 | Stirrup Push/Pull Curette ATP |
| 10888857556157 | One Sided Rasp, Right ATP |
| 10888857556140 | One Sided Rasp, Left ATP |
| 10888857556133 | Cobb, Right ATP, 60x22mm |
| 10888857556126 | Cobb, Right ATP, 60x18mm |
| 10888857556119 | Cobb, Left ATP, 60x22 mm |
| 10888857556102 | Cobb, Left ATP, 60x18 mm |
| 10888857556096 | Cobb, Right ATP, 50x22mm |
| 10888857556089 | Cobb, Right ATP, 50x18mm |
| 10888857556232 | Box Chisel ATP, 10mm |
| 10888857556225 | Box Chisel ATP, 8mm |
| 10888857556218 | Box Chisel ATP, 6mm |
| 10888857562042 | Pituitary ATP, 5mm |
| 10888857562035 | Pituitary ATP, 3mm |