Octane M

GUDID 00840996153508

OCTANE M,GEAR INSERTER HANDLE

Choice Spine, LP

Polymeric spinal interbody fusion cage

Primary Device ID	00840996153508
NIH Device Record Key	18460871-cf4b-49c9-9876-0d5afc8fee33
Commercial Distribution Status	In Commercial Distribution
Brand Name	Octane M
Version Model Number	05-049-04-2000
Company DUNS	078293017
Company Name	Choice Spine, LP
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	false
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	00840996153508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123607

FDA Product Code

LXH	Orthopedic manual surgical instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

[00840996153508]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-03-04
Device Publish Date	2024-02-24

On-Brand Devices [Octane M]

00840996153607	OCTANE M,IMPACTION CAP
00840996153591	OCTANE M,ANGLED POSITIONER
00840996153584	OCTANE M,STRAIGHT POSITIONER
00840996153577	OCTANE M,GRAFT PUSHER
00840996153560	OCTANE M, GRAFT TUBE
00840996153539	OCTANE M,RAIL SHAFT,24MM
00840996153522	OCTANE M,RAIL SHAFT,26MM
00840996153515	OCTANE M,RAIL SHAFTS
00840996153508	OCTANE M,GEAR INSERTER HANDLE
00840996153492	OCTANE M,INSERTER RAIL
00840996153485	OCTANE M,GEAR INSERTER,24MM
00840996153478	OCTANE M,GEAR INSERTER,26MM
00840996153461	OCTANE M,GEAR DRIVE INSERTER
00840996153454	OCTANE M,RATCHET INSERTER HANDLE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.