| Primary Device ID | 00840019936415 |
| NIH Device Record Key | f057cc8c-9515-43e0-b9bf-55a593958066 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sure-Lok Extended Tab Pedicle Screw System |
| Version Model Number | 60-BK-5002 |
| Catalog Number | 60-BK-5002 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | 00840019936415 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
[00840019936415]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-06 |
| Device Publish Date | 2019-08-29 |
| 00840019922685 | Instrument & Implant Tray (Empty) |
| 00840019922678 | K-Wire, SS Trocar/Blunt Tip |
| 00840019922654 | K-Wire, NI Trocar/Blunt Tip |
| 00840019922647 | K-Wire, NI Trocar/Threaded |
| 00840019922630 | K-Wire 1.6mm Diameter, Rounded |
| 00840019922623 | "Perc" Kwire (.062 X 21.0) |
| 00840019922616 | "Perc" Kwire (.062 X 21.0) |
| 00840019922609 | cap screw inserter |
| 00840019922593 | Percutaneous screwdriver |
| 00840019922579 | Caliper |
| 00840019922555 | Rod Inserter - bayonneted |
| 00840019922548 | Bottle Cap Straight |
| 00840019922531 | Sleeve, Straight |
| 00840019922517 | Sleeve, All in One |
| 00840019922692 | Implant Tray (Empty) |
| 00840019922661 | K-Wire, SS Trocar/Threaded |
| 00840019922586 | Tab Remover |
| 00840019922562 | Anti Torque (closed) |
| 00840019922524 | Bottle Cap Reduction |
| 00840019909228 | Percutaneous Screw 8.5 X 55mm |
| 00840019908924 | Percutaneous Screw 5.5 X 30mm |
| 00840019908917 | Percutaneous Screw 5.5 X 25mm |
| 00840019909600 | 150mm straight rod |
| 00840019909594 | 140mm straight rod |
| 00840019909587 | 130mm straight rod |
| 00840019909570 | 120mm straight rod |
| 00840019909563 | 110mm straight rod |
| 00840019909556 | 100mm straight rod |
| 00840019909549 | 90mm Straight Rod |
| 00840019909532 | 80mm Straight Rod |
| 00840019909525 | 75mm Straight Rod |
| 00840019909518 | 70mm Straight Rod |
| 00840019909501 | 65mm Straight Rod |
| 00840019909495 | 60mm Straight Rod |
| 00840019909488 | 55mm Straight Rod |
| 00840019909471 | 50mm Straight Rod |
| 00840019909464 | 45mm Straight Rod |
| 00840019909457 | 40mm Straight Rod |
| 00840019909440 | 35mm Straight Rod |
| 00840019909433 | 150mm curved rod |
| 00840019909426 | 140mm curved rod |
| 00840019909419 | 130mm curved rod |
| 00840019909402 | 120mm curved rod |
| 00840019909396 | 110mm curved rod |
| 00840019909389 | 100mm curved rod |
| 00840019909372 | 90mm curved rod |
| 00840019909365 | 80mm curved rod |
| 00840019909358 | 75mm curved rod |
| 00840019909341 | 70mm curved rod |
| 00840019909334 | 65mm curved rod |