ShurFit Interbody System ALIF30-09

GUDID 00840019942799

30mm x 22mm x 9mm, 8° ALIF Interbody

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00840019942799
NIH Device Record Key16e71c6f-859b-4c9c-a890-d699d2dbb303
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit Interbody System
Version Model NumberALIF30-09
Catalog NumberALIF30-09
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019942799 [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

[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


[00840019942799]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-17
Device Publish Date2021-06-09

On-Brand Devices [ShurFit Interbody System]

0084001994290436mm x 25mm x 19mm, 9° ALIF Interbody
0084001994289836mm x 25mm x 17mm, 9° ALIF Interbody
0084001994288136mm x 25mm x 15mm, 9° ALIF Interbody
0084001994287436mm x 25mm x 13mm, 9° ALIF Interbody
0084001994286736mm x 25mm x 11mm, 9° ALIF Interbody
0084001994285036mm x 25mm x 9mm, 7° ALIF Interbody
0084001994284330mm x 22mm x 19mm, 10° ALIF Interbody
0084001994283630mm x 22mm x 17mm, 10° ALIF Interbody
0084001994282930mm x 22mm x 15mm, 10° ALIF Interbody
0084001994281230mm x 22mm x 13mm, 10° ALIF Interbody
0084001994280530mm x 22mm x 11mm, 10° ALIF Interbody
0084001994279930mm x 22mm x 9mm, 8° ALIF Interbody

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