| Primary Device ID | 10888857553675 |
| NIH Device Record Key | 2d3d9a25-0312-4374-8eca-5d24ba91cb1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NAPA Access System |
| Version Model Number | 8030-90020 |
| Catalog Number | 8030-90020 |
| 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 | 10888857553675 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
Moist Heat or Steam Sterilization
[10888857553675]
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 |
| 10888857562974 | Instrument Tub |
| 10888857562967 | Instrument Tub |
| 10888857562950 | Caddy |
| 10888857562837 | Instrument Tray |
| 10888857562820 | Instrument Tray |
| 10888857562813 | Instrument Tray |
| 10888857562806 | Instrument Tray |
| 10888857562790 | Instrument Tray |
| 10888857562783 | Instrument Tray |
| 10888857556386 | Retractor Arm, Left ATP |
| 10888857556379 | Retractor Arm, Right ATP |
| 10888857556362 | Retractor Rack ATP |
| 10888857555884 | Coupler |
| 10888857555815 | Mini Arm, Double Clip |
| 10888857555808 | Mini Arm, Threaded Adaptor |
| 10888857555631 | Lipped Blade 24mm, 240mm |
| 10888857555624 | Lipped Blade 24mm, 230mm |
| 10888857555617 | Lipped Blade 24mm, 220mm |
| 10888857555600 | Lipped Blade 24mm, 210mm |
| 10888857555594 | Lipped Blade 24mm, 200mm |
| 10888857555587 | Lipped Blade 24mm, 190mm |
| 10888857555570 | Lipped Blade 24mm, 180mm |
| 10888857555563 | Lipped Blade 24mm, 170mm |
| 10888857555556 | Lipped Blade 24mm, 160mm |
| 10888857555549 | Lipped Blade 24mm, 150mm |
| 10888857555532 | Lipped Blade 24mm, 140mm |
| 10888857555525 | Lipped Blade 24mm, 130mm |
| 10888857555518 | Lipped Blade 24mm, 120mm |
| 10888857555501 | Lipped Blade 24mm, 110mm |
| 10888857555495 | Lipped Blade 24mm, 100mm |
| 10888857555488 | Lipped Blade 24mm, 90mm |
| 10888857555471 | Lipped Blade 24mm, 80mm |
| 10888857555464 | Lipped Blade 19mm, 240mm |
| 10888857555457 | Lipped Blade 19mm, 230mm |
| 10888857555440 | Lipped Blade 19mm, 220mm |
| 10888857555433 | Lipped Blade 19mm, 210mm |
| 10888857555426 | Lipped Blade 19mm, 200mm |
| 10888857555419 | Lipped Blade 19mm, 190mm |
| 10888857555402 | Lipped Blade 19mm, 180mm |
| 10888857555396 | Lipped Blade 19mm, 170mm |
| 10888857555389 | Lipped Blade 19mm, 160mm |
| 10888857555372 | Lipped Blade 19mm, 150mm |
| 10888857555365 | Lipped Blade 19mm, 140mm |
| 10888857555358 | Lipped Blade 19mm, 130mm |
| 10888857555341 | Lipped Blade 19mm, 120mm |
| 10888857555334 | Lipped Blade 19mm, 110mm |
| 10888857555327 | Lipped Blade 19mm, 100mm |
| 10888857555310 | Lipped Blade 19mm, 90mm |
| 10888857555303 | Lipped Blade 19mm, 80mm |
| 10888857555297 | Hohmann Blade 24mm, 240mm |