Elite Expandable Interbody Fusion System 100-1361

GUDID M7401001361

CEI 595 Shaver, 7mm

SPINEOLOGY INC.

Neurosurgical curette, reusable
Primary Device IDM7401001361
NIH Device Record Key94d24f32-b70f-4aec-b1c1-75bd8b11b617
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite Expandable Interbody Fusion System
Version Model Number102-83-01-02
Catalog Number100-1361
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7401001361 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


[M7401001361]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

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
M7401001369CEI 595 Shaver, 15mm
M7401001368CEI 595 Shaver, 14mm
M7401001367CEI 595 Shaver, 13mm
M7401001366CEI 595 Shaver, 12mm
M7401001365CEI 595 Shaver, 11mm
M7401001364CEI 595 Shaver, 10mm
M7401001363CEI 595 Shaver, 9mm
M7401001362CEI 595 Shaver, 8mm
M7401001361CEI 595 Shaver, 7mm
M7401001360CEI 595 Shaver, 6mm

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