Primary Device ID | 00815362028773 |
NIH Device Record Key | 13410146-6156-4788-8d4f-f99eab5ca5d0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Reform Pedicle Screw System |
Version Model Number | 39-MU-5535 |
Catalog Number | 39-MU-5535 |
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 | 00815362028773 [Primary] |
KWP | Appliance, Fixation, Spinal Interlaminal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
[00815362028773]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-05-24 |
Device Publish Date | 2019-05-16 |
00840019901826 | ø5.5 x 600mm STRAIGHT ROD (Ti) |
00840019900034 | ø10.5 x 90 mm POLYAXIAL SCREW |
00840019900027 | ø10.5 x 80 mm POLYAXIAL SCREW |
00840019900010 | ø10.5 x 70 mm POLYAXIAL SCREW |
00840019900003 | ø10.5 x 60 mm POLYAXIAL SCREW |
00815362028964 | ø10.5 x 55 mm POLYAXIAL SCREW |
00815362028957 | ø10.5 x 50 mm POLYAXIAL SCREW |
00815362028940 | ø10.5 x 45 mm POLYAXIAL SCREW |
00815362028933 | ø10.5 x 40 mm POLYAXIAL SCREW |
00815362028926 | ø10.5 x 120 mm POLYAXIAL SCREW |
00815362028919 | ø10.5 x 110 mm POLYAXIAL SCREW |
00815362028902 | ø10.5 x 100 mm POLYAXIAL SCREW |
00815362028896 | Ø7.5mm x 50mm MIS Uniplanar Screw |
00815362028889 | Ø7.5mm x 45mm MIS Uniplanar Screw |
00815362028872 | Ø7.5mm x 40mm MIS Uniplanar Screw |
00815362028865 | Ø7.5mm x 35mm MIS Uniplanar Screw |
00815362028858 | Ø6.5mm x 50mm MIS Uniplanar Screw |
00815362028841 | Ø6.5mm x 45mm MIS Uniplanar Screw |
00815362028834 | Ø6.5mm x 40mm MIS Uniplanar Screw |
00815362028827 | Ø6.5mm x 35mm MIS Uniplanar Screw |
00815362028810 | Ø6.5mm x 30mm MIS Uniplanar Screw |
00815362028803 | Ø5.5mm x 50mm MIS Uniplanar Screw |
00815362028797 | Ø5.5mm x 45mm MIS Uniplanar Screw |
00815362028780 | Ø5.5mm x 40mm MIS Uniplanar Screw |
00815362028773 | Ø5.5mm x 35mm MIS Uniplanar Screw |
00815362028766 | Ø5.5mm x 30mm MIS Uniplanar Screw |
00815362028759 | Ø5.5mm x 25mm MIS Uniplanar Screw |
00815362028742 | Ø4.5mm x 45mm MIS Uniplanar Screw |
00815362028735 | Ø4.5mm x 40mm MIS Uniplanar Screw |
00815362028728 | Ø4.5mm x 35mm MIS Uniplanar Screw |
00815362028711 | Ø4.5mm x 30mm MIS Uniplanar Screw |
00815362028704 | Ø4.5mm x 25mm MIS Uniplanar Screw |
00815362028698 | Modular Polyaxial Reduction Tulip Assembly |
00815362028681 | Modular Polyaxial Tulip Assembly |
00815362028674 | Modular Polyaxial Bone Screw Ø9.5mm x 90mm |
00815362028667 | Modular Polyaxial Bone Screw Ø9.5mm x 80mm |
00815362028650 | Modular Polyaxial Bone Screw Ø9.5mm x 70mm |
00815362028643 | Modular Polyaxial Bone Screw Ø9.5mm x 60mm |
00815362028636 | Modular Polyaxial Bone Screw Ø9.5mm x 55mm |
00815362028612 | Modular Polyaxial Bone Screw Ø9.5mm x 45mm |
00815362028605 | Modular Polyaxial Bone Screw Ø9.5mm x 40mm |
00815362028599 | Modular Polyaxial Bone Screw Ø9.5mm x 120mm |
00815362028582 | Modular Polyaxial Bone Screw Ø9.5mm x 110mm |
00815362028575 | Modular Polyaxial Bone Screw Ø9.5mm x 100mm |
00815362028568 | Modular Polyaxial Bone Screw Ø8.5mm x 90mm |
00815362028551 | Modular Polyaxial Bone Screw Ø8.5mm x 80mm |
00815362028544 | Modular Polyaxial Bone Screw Ø8.5mm x 70mm |
00815362028537 | Modular Polyaxial Bone Screw Ø8.5mm x 60mm |
00815362028520 | Modular Polyaxial Bone Screw Ø8.5mm x 55mm |
00815362028513 | Modular Polyaxial Bone Screw Ø8.5mm x 50mm |