ShurFit MALIF Interbody System 23-9101

GUDID 00840019936880

ShurFit™ MALIF Instrument Case # 1

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019936880
NIH Device Record Keyd64ce4b4-45a7-466e-a553-99d6d6726894
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit MALIF Interbody System
Version Model Number23-9101
Catalog Number23-9101
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 Usefalse
Lot Batchfalse
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
GS100840019936880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019936880]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-08-30

On-Brand Devices [ShurFit MALIF Interbody System]

00840019936903ShurFit™ MALIF Implant Case
00840019936897ShurFit™ MALIF Instrument Case # 2
00840019936880ShurFit™ MALIF Instrument Case # 1
00840019925389Angled Cobb 18mm
00840019925372Straight Cobb 22mm

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