RISE-L

GUDID 00889095308105

RISE-L Spacer 18 x 35mm, 7-14mm, 3-15°

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage
Primary Device ID00889095308105
NIH Device Record Keya2430bb8-de65-476e-8551-804357836fba
Commercial Distribution StatusIn Commercial Distribution
Brand NameRISE-L
Version Model Number193.501
Company DUNS139105691
Company NameGLOBUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)930-1800
Emailinfo@globusmedical.com

Device Dimensions

Height7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889095308105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889095308105]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-12-17

On-Brand Devices [RISE-L]

00889095308235RISE-L Spacer 22 x 65mm, 7-14mm, 3-15°
00889095308228RISE-L Spacer 22 x 60mm, 7-14mm, 3-15°
00889095308211RISE-L Spacer 22 x 55mm, 7-14mm, 3-15°
00889095308204RISE-L Spacer 22 x 50mm, 7-14mm, 3-15°
00889095308198RISE-L Spacer 22 x 45mm, 7-14mm, 3-15°
00889095308181RISE-L Spacer 22 x 40mm, 7-14mm, 3-15°
00889095308174RISE-L Spacer 22 x 35mm, 7-14mm, 3-15°
00889095308167RISE-L Spacer 18 x 65mm, 7-14mm, 3-15°
00889095308150RISE-L Spacer 18 x 60mm, 7-14mm, 3-15°
00889095308143RISE-L Spacer 18 x 55mm, 7-14mm, 3-15°
00889095308136RISE-L Spacer 18 x 50mm, 7-14mm, 3-15°
00889095308129RISE-L Spacer 18 x 45mm, 7-14mm, 3-15°
00889095308112RISE-L Spacer 18 x 40mm, 7-14mm, 3-15°
00889095308105RISE-L Spacer 18 x 35mm, 7-14mm, 3-15°

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.