ShurFit Interbody Deviceem 26-221000-12

GUDID 00840019910224

Wide PLIF Cage Peek 0 degree 22 x 10 X 12

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00840019910224
NIH Device Record Key19fe4176-f7bf-4e07-934f-31a64157adde
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit Interbody Deviceem
Version Model Number26-221000-12
Catalog Number26-221000-12
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 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
GS100840019910224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019910224]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-04-23

Devices Manufactured by PRECISION SPINE, INC.

00840019956567 - ShurFit Lumbar Interbody2025-06-06 32 x 11mm 12° Oblique PEEK 2C Interbody
00840019956574 - ShurFit Lumbar Interbody2025-06-06 32 x 12mm 12° Oblique PEEK 2C Interbody
00840019956581 - ShurFit Lumbar Interbody2025-06-06 32 x 13mm 12° Oblique PEEK 2C Interbody
00840019956598 - ShurFit Lumbar Interbody2025-06-06 32 x 14mm 12° Oblique PEEK 2C Interbody
00840019956604 - ShurFit Lumbar Interbody2025-06-06 32 x 15mm 12° Oblique PEEK 2C Interbody
00840019956611 - ShurFit Lumbar Interbody2025-06-06 32 x 16mm 12° Oblique PEEK 2C Interbody
00840019956628 - ShurFit Lumbar Interbody2025-06-06 32 x 12mm 16° Oblique PEEK 2C Interbody
00840019956635 - ShurFit Lumbar Interbody2025-06-06 32 x 13mm 16° Oblique PEEK 2C Interbody

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