| Primary Device ID | 00841132186671 |
| NIH Device Record Key | 97485a1b-2841-48df-8c17-a06c5f8328aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3P Hip System |
| Version Model Number | 01-3050-0014 |
| Catalog Number | 01-3050-0014 |
| 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 | 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(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 | 00841132186671 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
[00841132186671]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-27 |
| Device Publish Date | 2025-06-19 |
| 00841132190999 | 3P 5.0mm Transphyseal Screw Caddy |
| 00841132190982 | 3P 5.0mm Screw Prep Upper Tray |
| 00841132190975 | 3P 5.0mm Screw Prep Lower Tray |
| 00841132190968 | 3P 5.0mm Screw Caddy |
| 00841132190951 | 3P 3.5mm Transphyseal Screw Caddy |
| 00841132190944 | 3P XL Screw Caddy |
| 00841132190937 | 3P 3.5mm Screw Prep Upper Tray |
| 00841132190920 | 3P 3.5mm Screw Prep Lower Tray |
| 00841132190913 | 3P 3.5mm Screw Caddy |
| 00841132190906 | 3P Beam - Trauma Upper Tray |
| 00841132190890 | 3P Beam - Trauma Lower Tray |
| 00841132190883 | 3P Beam - Child Trauma Caddy |
| 00841132190876 | 3P Beam - Transphyseal Caddy |
| 00841132190869 | 3P LPF - Upper Tray |
| 00841132190791 | 3P LPF - Lower Tray |
| 00841132187654 | 3P Adolescent Beam - Overlap Gauge 110°/120°, Wide |
| 00841132187647 | 3P Adolescent Beam - Overlap Gauge 90°/100°, Wide |
| 00841132187616 | 3P Adolescent Beam - Upper Tray |
| 00841132187609 | 3P Adolescent Beam - Lower Tray |
| 00841132187593 | 3P Adolescent Beam - Caddy |
| 00841132187586 | 3P Adolescent Beam - Overlap Gauge 110°/120° |
| 00841132187579 | 3P Child Beam - Upper Tray |
| 00841132187562 | 3P Child Beam - Lower Tray |
| 00841132187555 | 3P Child Beam - Caddy |
| 00841132187548 | 3P Child Beam - Overlap Gauge 110°/120° |
| 00841132187531 | 3P Infant Beam - Upper Tray |
| 00841132187524 | 3P Infant Beam - Lower Tray |
| 00841132187517 | 3P Infant Beam - Caddy |
| 00841132187500 | 3P Infant Beam - Overlap Gauge 110°/120° |
| 00841132187494 | Triangular Positioning Plate 110°/60°/10° |
| 00841132187487 | 3P Adolescent Bone Clamp |
| 00841132187470 | 3P Child Bone Clamp |
| 00841132187463 | Power Adaptor, ZH to 1/4" Square |
| 00841132187456 | Fixed Ball Handle, AO QC |
| 00841132187449 | Ratcheting Axial Handle, AO QC |
| 00841132187432 | Fixed T-Handle, ZH QC |
| 00841132187425 | Ratcheting T-Handle, ZH QC |
| 00841132187418 | 2.8mm x 250mm Smooth Guide Wire |
| 00841132187401 | 2.8mm x 250mm Threaded Guide Wire |
| 00841132187395 | 3.5mm/4.3mm Drill Depth Indicator |
| 00841132187388 | 2.5mm/2.8mm Drill Depth Indicator |
| 00841132187159 | 3P 3.5mm XL Calibrated Drill |
| 00841132187142 | 3P 2.5mm XL Calibrated Drill |
| 00841132186718 | 3P 4.5mm Cannulated Hex Driver |
| 00841132186701 | 3P Direct Measuring Device, 2.8mm x 250mm Wire |
| 00841132186695 | 3P T15 Retaining Driver, Long |
| 00841132186688 | 3P T20 Retaining Driver, Long |
| 00841132186671 | 3P 3.5mm Double Drill Guide |
| 00841132186664 | 3P 3.5mm Calibrated Drill |
| 00841132186657 | 3P 4.3mm Calibrated Drill |