Elite Expandable Interbody Fusion System 301-0094

GUDID M7403010094

8mm Paddle Distractor

SPINEOLOGY INC.

Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable Spinal intraoperative positioning pin, reusable
Primary Device IDM7403010094
NIH Device Record Key7a5e92d1-b88c-457e-85b2-a0b28f2f1184
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite Expandable Interbody Fusion System
Version Model Number35-04-04-1
Catalog Number301-0094
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7403010094 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

[M7403010094]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

On-Brand Devices [Elite Expandable Interbody Fusion System]

M7401001054Elite Inserter Fork
M7401001249Asm, 10 mm Fork
M7405409401Torque-Limit Handle
M7405408951Elite Release Tool
M74030101767mm Paddle Distractor
M74030100959mm Paddle Distractor
M74030100948mm Paddle Distractor
M740301003116mm Paddle Distractor
M740301003015mm Paddle Distractor
M740301002914mm Paddle Distractor
M740301002813mm Paddle Distractor
M740301002712mm Paddle Distractor
M740301002611mm Paddle Distractor
M740301002510mm Paddle Distractor
M7403010022T-Handle
M7403010013Mallet
M7402800051Slap Hammer
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