Primary Device ID | 08406061016059 |
NIH Device Record Key | 1f935e85-c8f7-4e5e-ac66-0021a886f831 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lotus |
Version Model Number | 32526-000 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, 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 | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Phone | +1 (760) 607 0121 |
info@spinalelements.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08406061016059 [Primary] |
KWP | Appliance, Fixation, Spinal Interlaminal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08406061016059]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-04-09 |
Device Publish Date | 2019-02-18 |
08406061016097 | Offset Connector, 15mm |
08406061016073 | Offset Connector, 11mm |
08406061016059 | Hook, 5mm Right Angled |
08406061016042 | Hook, 5mm Left Angled |
08406061016035 | Hook, 6mm Straight |
08406061016028 | Hook, 5mm Straight |
08406061016011 | Hook, 4mm Straight |
08406061016004 | Ø4.5mm X 40mm Polyaxial Screw |
08406061015991 | Ø4.5mm X 38mm Polyaxial Screw |
08406061015984 | Ø4.5mm X 36mm Polyaxial Screw |
08406061015977 | Ø4.5mm X 34mm Polyaxial Screw |
08406061015960 | Ø4.5mm X 32mm Polyaxial Screw |
08406061015953 | Ø4.5mm X 30mm Polyaxial Screw |
08406061015946 | Ø4.5mm X 28mm Polyaxial Screw |
08406061015939 | Ø4.5mm X 26mm Polyaxial Screw |
08406061015922 | Ø4.5mm X 24mm Polyaxial Screw |
08406061015915 | Ø4.5mm X 22mm Polyaxial Screw |
08406061015908 | Ø4.5mm X 20mm Polyaxial Screw |
08406061015892 | Ø4.5mm X 18mm Polyaxial Screw |
08406061015885 | Ø4.5mm X 16mm Polyaxial Screw |
08406061015878 | Ø4.5mm X 14mm Polyaxial Screw |
08406061015861 | Ø4.5mm X 12mm Polyaxial Screw |
08406061015854 | Ø4.5mm X 10mm Polyaxial Screw |
08406061007743 | Ø5.5MM PARALLEL ROD TO ROD CONNECTOR |
08406061007736 | Ø5.5MM AXIAL ROD TO ROD CONNECTOR |
08406061007729 | Offset Connector 15MM |
08406061007712 | Offset Connector 13MM |
08406061007705 | Offset Connector 11MM |
08406061007699 | Offset Connector 9MM |
08406061007682 | Threaded Cap |
08406061007675 | Ø4.0mm X 38mm Polyaxial Screw 18mm Smooth Shank |
08406061007668 | Ø4.0mm X 35mm Polyaxial Screw 17mm Smooth Shank |
08406061007651 | Ø4.0mm X 42mm Polyaxial Screw 16mm Smooth Shank |
08406061007644 | Ø4.0mm X 40mm Polyaxial Screw 16mm Smooth Shank |
08406061007637 | Ø4.0mm X 37mm Polyaxial Screw 15mm Smooth Shank |
08406061007620 | Ø4.0mm X 35mm Polyaxial Screw 15mm Smooth Shank |
08406061007613 | Ø4.0mm X 32mm Polyaxial Screw 14mm Smooth Shank |
08406061007606 | Ø4.0mm X 30mm Polyaxial Screw 14mm Smooth Shank |
08406061007590 | Ø4.0mm X 39mm Polyaxial Screw 13mm Smooth Shank |
08406061007583 | Ø4.0mm X 37mm Polyaxial Screw 13mm Smooth Shank |
08406061007576 | Ø4.0mm X 34mm Polyaxial Screw 12mm Smooth Shank |
08406061007569 | Ø4.0mm X 32mm Polyaxial Screw 12mm Smooth Shank |
08406061007552 | Ø4.0mm X 32mm Polyaxial Screw 11mm Smooth Shank |
08406061007545 | Ø4.0mm X 30mm Polyaxial Screw 11mm Smooth Shank |
08406061007538 | Ø4.0mm X 29mm Polyaxial Screw 11mm Smooth Shank |
08406061007521 | Ø4.0mm X 28mm Polyaxial Screw 11mm Smooth Shank |
08406061007514 | Ø4.0mm X 27mm Polyaxial Screw 11mm Smooth Shank |
08406061007507 | Ø4.0mm X 36mm Polyaxial Screw 10mm Smooth Shank |
08406061007491 | Ø4.0mm X 34mm Polyaxial Screw 10mm Smooth Shank |
08406061007484 | Ø4.0mm X 31mm Polyaxial Screw 9mm Smooth Shank |