| Primary Device ID | 00841132122389 |
| NIH Device Record Key | ed898e49-0157-4a72-8336-4a52a37c615f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Locking Proximal Femur Plate System (LPF) |
| Version Model Number | 01-0907-0025 |
| Catalog Number | 01-0907-0025 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132122389 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
[00841132122389]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
| 00841132123676 | 140° X 4.5MM PLATE, 4 HOLE |
| 00841132122440 | Ø 1.6MM X Ø600MM GUIDE WIRE, BLUNT |
| 00841132122433 | 3.2MM X 200MM GUIDE WIRE, SMOOTH |
| 00841132122426 | 5.0MM X 200MM GUIDE WIRE, SMOOTH |
| 00841132122419 | 2.0MM X 230MM GUIDE WIRE, SMOOTH |
| 00841132122402 | 1.6MM X 230MM GUIDE WIRE, SMOOTH |
| 00841132122396 | 2.0MM X 150MM GUIDE WIRE, SMOOTH |
| 00841132122389 | 2.5MM X 200MM GUIDE WIRE, COCR |
| 00841132122372 | 2.0 MM X 150 MM GUIDE WIRE (COCR) |
| 00841132122365 | 2.0MM X 230MM GUIDE WIRE, COCR |
| 00841132122358 | 1.6MM X 230MM GUIDE WIRE, COCR |
| 00841132122341 | 2.0 MM X 150 MM GUIDE WIRE |
| 00841132122334 | T20 CANNULATED DRIVER |
| 00841132122327 | T15 CANNULATED DRIVER |
| 00841132122310 | 3.5 MM CANNULATED DRILL BIT |
| 00841132122303 | 2.9 MM CANNULATED DRILL BIT |
| 00841132122297 | 2.0MM X 230MM GUIDE WIRE |
| 00841132122280 | 1.6MM X 230MM GUIDE WIRE |
| 00841132122273 | T15 RETAINING DRIVER, SHORT |
| 00841132122266 | T15 HEXALOBE DRIVER, SHORT |
| 00841132100042 | 3.2MM X 200MM GUIDE WIRE, COCR |
| 00841132100035 | 90° X 3.5 MM VARUS PLATE 6 MM OFFSET, 3 HOLE |
| 00840194462983 | 130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 5 HOLE |
| 00840194462976 | 130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 4 HOLE |
| 00840194462969 | 130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 3 HOLE |
| 00840194462952 | 130° X 4.5MM VALGUS PLATES,14MM OFFSET, 5 HOLE |
| 00840194462945 | 130° X 4.5MM VALGUS PLATES,14MM OFFSET, 4 HOLE |
| 00840194462938 | 130° X 4.5MM VALGUS PLATES,14MM OFFSET, 3 HOLE |