Primary Device ID | B114165550 |
NIH Device Record Key | bf38a8d1-37c3-42a2-b024-774d85036f3a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Calvary Spine Pedicle Screw System |
Version Model Number | 16555 |
Catalog Number | 16555 |
Company DUNS | 832116532 |
Company Name | CALVARY SPINE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B114165550 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
[B114165550]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-02 |
Device Publish Date | 2020-11-24 |
B165350 | Polyaxial Screw 7.5mm Diameter 35mm length |
B115185450 | Polyaxial Screw 8.5mm Diameter 45mm length |
B11485400 | Polyaxial Screw 8.5mm Diameter 40mm length |
B1148500 | Illiac Connector 5.5mm Diameter 50mm Rod Length |
B1148300 | Illiac Connector 5.5mm Diameter 30mm Rod Length |
B11475550 | Polyaxial Screw 7.5mm Diameter 55mm length |
B11475500 | Polyaxial Screw 7.5mm Diameter 50mm length |
B11475300 | Polyaxial Screw 7.5mm Diameter 30mm length |
B1145900 | PreLordosed Rod 5.5mm Diameter 90mm length Ti6Al4V |
B1145800 | PreLordosed Rod 5.5mm Diameter 80mm length Ti6Al4V |
B1145700 | PreLordosed Rod 5.5mm Diameter 70mm length Ti6Al4V |
B1145600 | PreLordosed Rod 5.5mm Diameter 60mm length Ti6Al4V |
B1145500 | PreLordosed Rod 5.5mm Diameter 50mm length Ti6Al4V |
B11454800 | Straight Rod 5.5mm Diameter 480mm length Ti6Al4V |
B1145450 | PreLordosed Rod 5.5mm Diameter 45mm length Ti6Al4V |
B1145400 | PreLordosed Rod 5.5mm Diameter 40mm length Ti6Al4V |
B1145350 | PreLordosed Rod 5.5mm Diameter 35mm length Ti6Al4V |
B1145300 | PreLordosed Rod 5.5mm Diameter 30mm length Ti6Al4V |
B11452400 | PreLordosed Rod 5.5mm Diameter 240mm length Ti6Al4V |
B11451000 | PreLordosed Rod 5.5mm Diameter 100mm length Ti6Al4V |
B114185900 | Polyaxial Screw 8.5mm Diameter 90mm length |
B114185800 | Polyaxial Screw 8.5mm Diameter 80mm length |
B114185700 | Polyaxial Screw 8.5mm Diameter 70mm length |
B114185600 | Polyaxial Screw 8.5mm Diameter 60mm length |
B114185550 | Polyaxial Screw 8.5mm Diameter 55mm length |
B114185500 | Polyaxial Screw 8.5mm Diameter 50mm length |
B11418535 | Polyaxial Screw 8.5mm Diameter 35mm length |
B114185300 | Polyaxial Screw 8.5mm Diameter 30mm length |
B114175600 | Polyaxial Screw 7.5mm Diameter 60mm length |
B114175450 | Polyaxial Screw 7.5mm Diameter 45mm length |
B114175400 | Polyaxial Screw 7.5mm Diameter 40mm length |
B114165600 | Polyaxial Screw 6.5mm Diameter 60mm length |
B114165550 | Polyaxial Screw 6.5mm Diameter 55mm length |
B114165500 | Polyaxial Screw 6.5mm Diameter 50mm length |
B114165450 | Polyaxial Screw 6.5mm Diameter, 45mm length |
B114165400 | Polyaxial Screw 6.5mm Diameter 40mm length |
B114165350 | Polyaxial Screw 6.5mm Diameter 35mm length |
B114165300 | Polyaxial Screw 6.5mm Diameter 30mm length |
B114155600 | Polyaxial Screw 5.5mm Diameter 60mm length |
B114155550 | Polyaxial Screw 5.5mm Diameter 55mm length |
B114155500 | Polyaxial Screw 5.5mm Diameter 50mm length |
B114155450 | Polyaxial Screw 5.5mm Diameter 45mm length |
B114155400 | Polyaxial Screw 5.5mm 40 mm Length |
B114155350 | Polyaxial Screw 5.5mm Diameter 35mm length |
B114155300 | Polyaxial Screw 5.5mm diameter 30mm length |
B114155250 | Polyaxial Screw 5.5mm Diameter 25 mm length |
B11410010 | Locking Cap |