ROMEO 2 INSTRUMENTATION ELL-IN 04 10-N

GUDID 07640151093860

Setcrew holder

SpineArt SA

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 07640151093860
• NIH Device Record Key: 4fbe3dde-74db-4506-8361-df3fee897ec9
• Commercial Distribution Discontinuation: 2019-02-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ROMEO 2 INSTRUMENTATION
• Version Model Number: ELL-IN 04 10-N
• Catalog Number: ELL-IN 04 10-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640151093860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151695

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

[07640151093860]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-06
• Device Publish Date: 2016-09-27

On-Brand Devices [ROMEO 2 INSTRUMENTATION]

• 07640178982253: TAP Ø7 x 30
• 07640178982055: FINAL TIGHTENER 13 HEXAGON
• 07640178982048: FINAL TIGHTENER 13 HEXALOBE
• 07640178982024: TAP Ø6 x 30
• 07640178982017: TAP Ø5 x 30
• 07640178981959: PEDICLE PROBE LENKE STRAIGHT
• 07640178981942: PEDICLE PROBE LENKE CURVED
• 07640178981935: PEDICLE PROBE STRAIGHT
• 07640178981928: DEROTATION HANDLE
• 07640178981850: DRILL Ø3.2
• 07640178981843: ADJUSTABLE DRILL GUIDE
• 07640178981836: DRILL GUIDE
• 07640178981829: ROD TRIAL LONG
• 07640178981812: ROD TRIAL SHORT
• 07640178981805: REAMER
• 07640178981799: SCREWDRIVER SHAFT PS
• 07640178981744: FINE PITCH RATCHETING T-HANDLE
• 07640178981737: FINE PITCH STRAIGHT RATCHETING HANDLE
• 07640178980822: SETSCREW HOLDER H
• 07640178980815: RIBAC L
• 07640178980808: RIBAC R
• 07640178980464: SCREWDRIVER SHAFT PS STRAIGHT
• 07640178980136: TAP Ø 4 X 30
• 07640178980129: TAP Ø 4.5 X 30
• 07640178980112: TAP Ø 6.5 X 30
• 07640178980105: TAP Ø 5.5 X 30
• 07640178979901: 4.0 TIGHTENER
• 07640178975453: TAP Ø7 x 30
• 07640178975446: TAP Ø6 x 30
• 07640178975439: TAP Ø5 x 30
• 07640178975057: COUNTER TORQUE ADAPTED FOR BDYN IMPLANT
• 07640178975033: CLIPPING TUBE OPEN
• 07640178975026: CLIPPING TUBE
• 07640178975019: TROCAR 3 IN 1- LONG TIP AWL
• 07640178974999: QR REDUCER LINK - BRIDGE II
• 07640178974845: QR REDUCER Ti
• 07640178973862: SETSCREW HOLDER
• 07640178973855: FINAL TIGHTENER
• 07640178973848: SETSCREW TIGHTENER
• 07640178973039: COUNTER TORQUE 90°
• 07640178972896: COUNTER TORQUE
• 07640178972889: DRILL Ø 3.2 MM
• 07640178972803: RIBAC
• 07640178972797: QR REDUCER LINK - BRIDGE
• 07640178972780: QR REDUCER LINK
• 07640178972773: QR REDUCER
• 07640178972766: SETSCREW TUBE H
• 07640178972759: DUAL CALIPER
• 07640178972742: SETSCREW HOLDER H
• 07640178972575: VARIABLE ENDTIP ROD HOLDER