Rampart One Lumbar Interbody Fusion System 490-0003

GUDID M7404900003

Rampart One Guide, 14mm

SPINEOLOGY INC.

Polymeric spinal fusion cage, sterile
Primary Device IDM7404900003
NIH Device Record Key4b6cc7e6-ee59-48ca-a086-6690ea88bdbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRampart One Lumbar Interbody Fusion System
Version Model Number49-12-12
Catalog Number490-0003
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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

Device Dimensions

Height14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7404900003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7404900003]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-10
Device Publish Date2019-07-02

On-Brand Devices [Rampart One Lumbar Interbody Fusion System]

M7404902207Rampart One Oblique Trial, 14mm, M, 8°
M7404902206Rampart One Oblique Trial, 12mm, M, 8°
M7404902205Rampart One Oblique Trial, 10.5mm, M, 8°
M7404902203Rampart One Oblique Trial, 14mm, S, 8°
M7404902202Rampart One Oblique Trial, 12mm, S, 8°
M7404902201Rampart One Oblique Trial, 10.5mm, S, 8°
M7404902028Rampart One Trial Inserter
M7404902026Rampart One Trial, 16mm, L, 12°
M7404902025Rampart One Trial, 14mm, L, 12°
M7404902024Rampart One Trial, 12mm, L, 12°
M7404902022Rampart One Trial, 16mm, L, 8°
M7404902021Rampart One Trial, 14mm, L, 8°
M7404902020Rampart One Trial, 12mm, L, 8°
M7404902017Rampart One Trial, 16mm, M, 12°
M7404902016Rampart One Trial, 14mm, M, 12°
M7404902015Rampart One Trial, 12mm, M, 12°
M7404902013Rampart One Trial, 16mm, M, 8°
M7404902012Rampart One Trial, 14mm, M, 8°
M7404902011Rampart One Trial, 12mm, M, 8°
M7404902010Rampart One Trial, 10.5mm, M, 8°
M7404902007Rampart One Trial, 14mm, S, 12°
M7404902006Rampart One Trial, 12mm, S, 12°
M7404902003Rampart One Trial, 14mm, S, 8°
M7404902002Rampart One Trial, 12mm, S, 8°
M7404902001Rampart One Trial, 10.5mm, S, 8°
M7404900011Rampart One Inserter
M7404901823Rampart One Inserter
M7404900006Rampart One Inserter Block
M7404900004Rampart One Guide, 16mm
M7404900003Rampart One Guide, 14mm
M7404900002Rampart One Guide, 12mm
M7404900001Rampart One Guide, 10.5mm
M7404902033Rampart One Trial, 18mm, M, 20°
M7404902032Rampart One Trial, 18mm, M, 16°
M7404902031Rampart One Trial, 16mm, M, 20°
M7404902030Rampart One Trial, 16mm, M, 16°
M7404902029Rampart One Trial, 14mm, M, 16°
M7404901822Rampart One Standard Spacer, 18mm, L, 20°
M7404901821Rampart One Standard Spacer, 18mm, L, 16°
M7404901820Rampart One Standard Spacer, 18mm, S, 16°
M7404901819Rampart One Standard Spacer, 18mm, S, 20°
M7404901818Rampart One Standard Spacer, 18mm, M, 20°
M7404901817Rampart One Standard Spacer, 18mm, M, 16°
M7404901612Rampart One Standard Spacer, 16mm, L, 20°
M7404901611Rampart One Standard Spacer, 16mm, L, 16°
M7404901610Rampart One Standard Spacer, 16mm, S, 20°
M7404901609Rampart One Standard Spacer, 16mm, S, 16°
M7404901608Rampart One Standard Spacer, 16mm, M, 20°
M7404901607Rampart One Standard Spacer, 16mm, M, 16°
M7404901410Rampart One Standard Spacer, 14mm, L, 16°
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