NIDO Pedicle Screw System 15-BCC-8595

GUDID B07315BCC85950

Bone Screw, Fenestrated Cortical, 8.5 x 95mm

Kalitec Direct LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB07315BCC85950
NIH Device Record Keyea246757-9dd7-4f28-99e2-2b4c19f2c3fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIDO Pedicle Screw System
Version Model Number15-BCC-8595
Catalog Number15-BCC-8595
Company DUNS041956211
Company NameKalitec Direct LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07315BCC85950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

[B07315BCC85950]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-06

On-Brand Devices [NIDO Pedicle Screw System]

B07315MLC00000Locking Cap, Modular Screws
B07315MHP12000Modular Tulip, Standard Closed
B07315MHP10000Modular Tulip, Standard
B07315MHE20000Modular Tulip, Extended Tab
B07315K1104250Tray, 4.25 Inch Base
B07315K1102000Tray, 2 inch base
B07315K1100140Implant Tray
B07315K1100110Tray Insert, Rod Connectors
B07315K1100100Tray Insert
B07315K1100090Tray Insert
B07315K1100080Tray Insert
B07315K1100070Tray Insert 1, NIDO
B07315K0430210Sagittal Bender, Double Ended Right
B07315K0430200Sagittal Bender, Double Ended Left
B07315K0160600Inserter, Dominoes
B07315K0160400Driver Shaft, T20 Final Domino Cap Driver
B07315K0160200T-Handle, T20 Dominoes Cap Starter
B07315K0160000Counter Torque, Dominoes
B07315K0140400Driver Shaft, T30 Final Cap Driver
B07315K0140200T-Handle, T30 Split Tip Cap Starter
B07315K0140000Counter Torque, Standard and Extended Tab
B07315K0132000Rod Reducer, Axial, NIDO
B07315K0131150Rocker, Hinged Locking
B07315K0131100Rocker, One Piece
B07315K0123200Inserter, Tulips and Connectors
B07315K0122100T-Handle, Head Persuader
B07315K0120200Screwdriver, Modular Bone Screws
B07315K0113100Decorticating Planer
B07315K0112080Tap, 7.50mm
B07315K0112060Tap, 6.50mm
B07315K0112040Tap, 5.50mm
B07315K0112020Tap, 4.75mm
B07315K0104100Caddie Lid, Tulip and Domino Connectors
B07315K0104000Caddie, Tulip Connectors
B07315K0103000Caddie, Domino Connectors
B07315K0101100Caddie Lid, Modular Heads, Polyaxial
B07315K0101000Caddie, Modular Heads, Polyaxial
B07315K0100610Caddie Lid, Modular Bone Screws
B07315K0100600Caddie, Modular Bone Screws
B07315K0100440Caddie, Locking Caps
B07315CTP40000Connector, Parallel Modular Tulip Open-Open, 5.5mm
B07315CTP31000Connector, Adjustable Parallel Tulips Open-Open, 5.5mm
B07315CTP30000Connector, Parallel Tulips Open-Open, 5.5mm
B07315CLA51300Connector, Lateral Tulip Open, 5.5 X 30mm
B07315CLA51200Connector, Lateral Tulip Open, 5.5 X 20mm
B07315CLA50300Connector, Lateral Tulip Closed, 5.5 X 30mm
B07315CLA50200Connector, Lateral Tulip Closed, 5.5 X 20mm
B07315CDS00000Set Screw, Dominoes
B07315CDP22100Domino, Parallel Open-Open, Small
B07315CDP22000Domino, Parallel Open-Open, Large
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