Palisade Pedicular Fixation System 670-4035

GUDID M7406704035

Fixed Curved Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod
Primary Device IDM7406704035
NIH Device Record Key263055c4-062c-49ef-9d4b-17305d5524b0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePalisade Pedicular Fixation System
Version Model Number10-10-59-3
Catalog Number670-4035
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com

Device Dimensions

Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0
Length35 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7406704035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

[M7406704035]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-22
Device Publish Date2016-03-01

On-Brand Devices [Palisade Pedicular Fixation System]

M7406704095Palisade Fixed Curved Rod
M7406700071All In One Stylet, Short, Non-Sterile
M7406700070All In One Stylet, Long, Non-Sterile
M7406710074Revision Tower Reducer
M7406710068ASM, Locking Cap Ratchet Handle
M7409000007Ratcheting Axial Handle
M7409000005Torque Limiting Handle
M7406710075Counter Torque
M7406710073Alignment Tool
M7406710072Bone Rasp
M7406710071Rescue Tower
M7406710070Tower Adjustment Tool
M7406710061Rasp
M7406710060Impaction Cap
M7406710059Palisade Trajectory Portal
M7406710058Bevel Awl
M7406710057Trocar Awl
M7406710053Screw Height Adjuster
M7406710052Dilator One
M7406710051Rescue Sleeve
M7406710050Palm Handle Set Screw Placer
M7406710049Tulip Head Turner
M7406710048Rod Caliper
M7406710040Double Ended Set Screw Placer
M7406710036Tab Breaker
M7406710035Counter Torque
M7406710030Straight Rod Holder
M7406710027Compressor/Distractor Link
M7406710025Compressor/Distractor Tube
M7406710024Compressor/Distractor Handle
M7406710016Screwdriver
M7406710008Dilator Three
M7406710007Dilator Two
M7406710005Articulating Rod Holder Guide
M7406710004Ring Breaker
M7406710002Locking Set Screw Placer
M7406420001Rod Holder
M7405300045Rod Bender
M7405300042Ratcheting T-Handle
M7406710055Short 1/4 Drive Final Driver
M74067100157.5mm Tap
M74067100146.5mm Tap
M74067100135.5mm Tap
M74067100124.5mm Tap
M7401001284Stylet Wrench
M7406710078Extra Short Palisade Driver
M7406700076All In One Stylet, Extra-Short, Sterile
M7406707590Pedicle Screw
M7406707580Pedicle Screw
M7406707570Pedicle Screw
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.