| Primary Device ID | 00840194444866 |
| NIH Device Record Key | 1ef71870-0e46-4133-9e84-5e87ea71767b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PNP Femur |
| Version Model Number | 11-1500-005-S |
| Catalog Number | 11-1500-005-S |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840194444866 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-05 |
| Device Publish Date | 2025-05-28 |
| 00841132195758 | Adolescent Nail Attachment Bolt, Single Use |
| 00841132195734 | 5.0mm Recon Screw Stepped Drill Bit, Calibrated, AO |
| 00841132195703 | Child Nail Attachment Bolt, Single Use |
| 00841132195680 | 4.5mm Recon Screw Stepped Drill Bit, Calibrated, AO |
| 00841132195536 | 5.0mm x 100mm Partially Threaded Recon Screw |
| 00841132195529 | 5.0mm x 98mm Partially Threaded Recon Screw |
| 00841132195512 | 5.0mm x 97.5mm Partially Threaded Recon Screw |
| 00841132195505 | 5.0mm x 96mm Partially Threaded Recon Screw |
| 00841132195499 | 5.0mm x 95mm Partially Threaded Recon Screw |
| 00841132195482 | 5.0mm x 94mm Partially Threaded Recon Screw |
| 00841132195475 | 5.0mm x 92.5mm Partially Threaded Recon Screw |
| 00841132195468 | 5.0mm x 92mm Partially Threaded Recon Screw |
| 00841132195451 | 5.0mm x 90mm Partially Threaded Recon Screw |
| 00841132195444 | 5.0mm x 88mm Partially Threaded Recon Screw |
| 00841132195437 | 5.0mm x 87.5mm Partially Threaded Recon Screw |
| 00841132195420 | 5.0mm x 86mm Partially Threaded Recon Screw |
| 00841132195413 | 5.0mm x 85mm Partially Threaded Recon Screw |
| 00841132195406 | 5.0mm x 84mm Partially Threaded Recon Screw |
| 00841132195390 | 5.0mm x 82.5mm Partially Threaded Recon Screw |
| 00841132195383 | 5.0mm x 82mm Partially Threaded Recon Screw |
| 00841132195376 | 5.0mm x 80mm Partially Threaded Recon Screw |
| 00841132195369 | 5.0mm x 78mm Partially Threaded Recon Screw |
| 00841132195352 | 5.0mm x 77.5mm Partially Threaded Recon Screw |
| 00841132195345 | 5.0mm x 76mm Partially Threaded Recon Screw |
| 00841132195338 | 5.0mm x 75mm Partially Threaded Recon Screw |
| 00841132195321 | 5.0mm x 74mm Partially Threaded Recon Screw |
| 00841132195314 | 5.0mm x 72.5mm Partially Threaded Recon Screw |
| 00841132195307 | 5.0mm x 72mm Partially Threaded Recon Screw |
| 00841132195291 | 5.0mm x 70mm Partially Threaded Recon Screw |
| 00841132195284 | 5.0mm x 68mm Partially Threaded Recon Screw |
| 00841132195277 | 5.0mm x 67.5mm Partially Threaded Recon Screw |
| 00841132195260 | 5.0mm x 66mm Partially Threaded Recon Screw |
| 00841132195253 | 5.0mm x 65mm Partially Threaded Recon Screw |
| 00841132195246 | 5.0mm x 64mm Partially Threaded Recon Screw |
| 00841132195239 | 5.0mm x 62.5mm Partially Threaded Recon Screw |
| 00841132195222 | 5.0mm x 62mm Partially Threaded Recon Screw |
| 00841132195215 | 5.0mm x 60mm Partially Threaded Recon Screw |
| 00841132195208 | 5.0mm x 58mm Partially Threaded Recon Screw |
| 00841132195192 | 5.0mm x 57.5mm Partially Threaded Recon Screw |
| 00841132195185 | 5.0mm x 56mm Partially Threaded Recon Screw |
| 00841132195178 | 5.0mm x 55mm Partially Threaded Recon Screw |
| 00841132195161 | 5.0mm x 54mm Partially Threaded Recon Screw |
| 00841132195154 | 5.0mm x 52.5mm Partially Threaded Recon Screw |
| 00841132195147 | 5.0mm x 52mm Partially Threaded Recon Screw |
| 00841132195130 | 5.0mm x 50mm Partially Threaded Recon Screw |
| 00841132195123 | 5.0mm x 48mm Partially Threaded Recon Screw |
| 00841132195116 | 5.0mm x 47.5mm Partially Threaded Recon Screw |
| 00841132195109 | 5.0mm x 46mm Partially Threaded Recon Screw |
| 00841132195093 | 5.0mm x 45mm Partially Threaded Recon Screw |
| 00841132195086 | 5.0mm x 44mm Partially Threaded Recon Screw |