Primary Device ID | 00815362025451 |
NIH Device Record Key | 79f7672d-aaca-44f2-8610-9ec7679ceefe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Reform Midline Cortical Screw System |
Version Model Number | 59-BC-5040 |
Catalog Number | 59-BC-5040 |
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 | true |
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 | 00815362025451 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
[00815362025451]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-05-14 |
Device Publish Date | 2019-05-06 |
00815362025741 | Ø7.5 x 80mm Midline Cortical Bone Screw, Cannulated |
00815362025734 | Ø7.5 x 70mm Midline Cortical Bone Screw, Cannulated |
00815362025727 | Ø7.5 x 60mm Midline Cortical Bone Screw, Cannulated |
00815362025710 | Ø7.5 x 55mm Midline Cortical Bone Screw, Cannulated |
00815362025703 | Ø7.5 x 50mm Midline Cortical Bone Screw, Cannulated |
00815362025697 | Ø7.5 x 45mm Midline Cortical Bone Screw, Cannulated |
00815362025680 | Ø7.5 x 40mm Midline Cortical Bone Screw, Cannulated |
00815362025673 | Ø7.5 x 35mm Midline Cortical Bone Screw, Cannulated |
00815362025666 | Ø7.5 x 30mm Midline Cortical Bone Screw, Cannulated |
00815362025659 | Ø6.5 x 60mm Midline Cortical Bone Screw, Cannulated |
00815362025642 | Ø6.5 x 55mm Midline Cortical Bone Screw, Cannulated |
00815362025635 | Ø6.5 x 50mm Midline Cortical Bone Screw, Cannulated |
00815362025628 | Ø6.5 x 45mm Midline Cortical Bone Screw, Cannulated |
00815362025611 | Ø6.5 x 40mm Midline Cortical Bone Screw, Cannulated |
00815362025604 | Ø6.5 x 35mm Midline Cortical Bone Screw, Cannulated |
00815362025598 | Ø6.5 x 30mm Midline Cortical Bone Screw, Cannulated |
00815362025581 | Ø6.5 x 25mm Midline Cortical Bone Screw, Cannulated |
00815362025574 | Ø5.5 x 60mm Midline Cortical Bone Screw, Cannulated |
00815362025567 | Ø5.5 x 55mm Midline Cortical Bone Screw, Cannulated |
00815362025550 | Ø5.5 x 50mm Midline Cortical Bone Screw, Cannulated |
00815362025543 | Ø5.5 x 45mm Midline Cortical Bone Screw, Cannulated |
00815362025536 | Ø5.5 x 40mm Midline Cortical Bone Screw, Cannulated |
00815362025529 | Ø5.5 x 35mm Midline Cortical Bone Screw, Cannulated |
00815362025512 | Ø5.5 x 30mm Midline Cortical Bone Screw, Cannulated |
00815362025505 | Ø5.5 x 25mm Midline Cortical Bone Screw, Cannulated |
00815362025499 | Ø5.0 x 60mm Midline Cortical Bone Screw, Cannulated |
00815362025482 | Ø5.0 x 55mm Midline Cortical Bone Screw, Cannulated |
00815362025475 | Ø5.0 x 50mm Midline Cortical Bone Screw, Cannulated |
00815362025468 | Ø5.0 x 45mm Midline Cortical Bone Screw, Cannulated |
00815362025451 | Ø5.0 x 40mm Midline Cortical Bone Screw, Cannulated |
00815362025444 | Ø5.0 x 35mm Midline Cortical Bone Screw, Cannulated |
00815362025437 | Ø5.0 x 30mm Midline Cortical Bone Screw, Cannulated |
00815362025420 | Ø5.0 x 25mm Midline Cortical Bone Screw, Cannulated |
00815362025406 | Ø4.5 x 45mm Midline Cortical Bone Screw, Cannulated |
00815362025390 | Ø4.5 x 40mm Midline Cortical Bone Screw, Cannulated |
00815362025383 | Ø4.5 x 35mm Midline Cortical Bone Screw, Cannulated |
00815362025376 | Ø4.5 x 30mm Midline Cortical Bone Screw, Cannulated |
00815362025369 | Ø4.5 x 25mm Midline Cortical Bone Screw, Cannulated |
00815362025352 | Ø10.5 x 90mm Midline Cortical Bone Screw, Cannulated |
00815362025345 | Ø10.5 x 80mm Midline Cortical Bone Screw, Cannulated |
00815362025338 | Ø10.5 x 70mm Midline Cortical Bone Screw, Cannulated |
00815362025321 | Ø10.5 x 60mm Midline Cortical Bone Screw, Cannulated |
00815362025314 | Ø10.5 x 55mm Midline Cortical Bone Screw, Cannulated |
00815362025307 | Ø10.5 x 50mm Midline Cortical Bone Screw, Cannulated |
00815362025291 | Ø10.5 x 45mm Midline Cortical Bone Screw, Cannulated |
00815362025284 | Ø10.5 x 40mm Midline Cortical Bone Screw, Cannulated |
00815362025277 | Ø10.5 x 120mm Midline Cortical Bone Screw, Cannulated |
00815362025260 | Ø10.5 x 110mm Midline Cortical Bone Screw, Cannulated |
00815362025253 | Ø10.5 x 100mm Midline Cortical Bone Screw, Cannulated |
00815362025246 | Ø4.75-Ø4.75 Axial Domino, Open-Closed |