| Primary Device ID | B07315K0120120 |
| NIH Device Record Key | 7543bdf3-7321-4ce9-b2c8-65a59c4cc6e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIDO Pedicle Screw System |
| Version Model Number | 15-K01-2012 |
| Catalog Number | 15-K01-2012 |
| Company DUNS | 041956211 |
| Company Name | Kalitec Direct LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
|---|---|
| HIBCC | B07315K0120120 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
[B07315K0120120]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-05-31 |
| B07315MLC00000 | Locking Cap, Modular Screws |
| B07315MHP12000 | Modular Tulip, Standard Closed |
| B07315MHP10000 | Modular Tulip, Standard |
| B07315MHE20000 | Modular Tulip, Extended Tab |
| B07315K1104250 | Tray, 4.25 Inch Base |
| B07315K1102000 | Tray, 2 inch base |
| B07315K1100140 | Implant Tray |
| B07315K1100110 | Tray Insert, Rod Connectors |
| B07315K1100100 | Tray Insert |
| B07315K1100090 | Tray Insert |
| B07315K1100080 | Tray Insert |
| B07315K1100070 | Tray Insert 1, NIDO |
| B07315K0430210 | Sagittal Bender, Double Ended Right |
| B07315K0430200 | Sagittal Bender, Double Ended Left |
| B07315K0160600 | Inserter, Dominoes |
| B07315K0160400 | Driver Shaft, T20 Final Domino Cap Driver |
| B07315K0160200 | T-Handle, T20 Dominoes Cap Starter |
| B07315K0160000 | Counter Torque, Dominoes |
| B07315K0140400 | Driver Shaft, T30 Final Cap Driver |
| B07315K0140200 | T-Handle, T30 Split Tip Cap Starter |
| B07315K0140000 | Counter Torque, Standard and Extended Tab |
| B07315K0132000 | Rod Reducer, Axial, NIDO |
| B07315K0131150 | Rocker, Hinged Locking |
| B07315K0131100 | Rocker, One Piece |
| B07315K0123200 | Inserter, Tulips and Connectors |
| B07315K0122100 | T-Handle, Head Persuader |
| B07315K0120200 | Screwdriver, Modular Bone Screws |
| B07315K0113100 | Decorticating Planer |
| B07315K0112080 | Tap, 7.50mm |
| B07315K0112060 | Tap, 6.50mm |
| B07315K0112040 | Tap, 5.50mm |
| B07315K0112020 | Tap, 4.75mm |
| B07315K0104100 | Caddie Lid, Tulip and Domino Connectors |
| B07315K0104000 | Caddie, Tulip Connectors |
| B07315K0103000 | Caddie, Domino Connectors |
| B07315K0101100 | Caddie Lid, Modular Heads, Polyaxial |
| B07315K0101000 | Caddie, Modular Heads, Polyaxial |
| B07315K0100610 | Caddie Lid, Modular Bone Screws |
| B07315K0100600 | Caddie, Modular Bone Screws |
| B07315K0100440 | Caddie, Locking Caps |
| B07315CTP40000 | Connector, Parallel Modular Tulip Open-Open, 5.5mm |
| B07315CTP31000 | Connector, Adjustable Parallel Tulips Open-Open, 5.5mm |
| B07315CTP30000 | Connector, Parallel Tulips Open-Open, 5.5mm |
| B07315CLA51300 | Connector, Lateral Tulip Open, 5.5 X 30mm |
| B07315CLA51200 | Connector, Lateral Tulip Open, 5.5 X 20mm |
| B07315CLA50300 | Connector, Lateral Tulip Closed, 5.5 X 30mm |
| B07315CLA50200 | Connector, Lateral Tulip Closed, 5.5 X 20mm |
| B07315CDS00000 | Set Screw, Dominoes |
| B07315CDP22100 | Domino, Parallel Open-Open, Small |
| B07315CDP22000 | Domino, Parallel Open-Open, Large |