INTERBODY FUSION ALIF0826-15P

GUDID 00815362023105

ALIF CAGE 8 DEG - 15MM (QTY 29 )

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00815362023105
NIH Device Record Keydc182e9f-3965-4a57-92a4-b67112b11fca
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTERBODY FUSION
Version Model Number1311TS
Catalog NumberALIF0826-15P
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
GS100815362023105 [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

[00815362023105]

Moist Heat or Steam Sterilization


[00815362023105]

Moist Heat or Steam Sterilization


[00815362023105]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-12-05

On-Brand Devices [INTERBODY FUSION]

00815362023242SHURFIT LLIF PEEK 22x60x14mm (qty 13)
00815362023211ALIF CAGE 15DEG- 19MM (QTY 21)
00815362023204ALIF CAGE 15DEG - 19MM (QTY 29)
00815362023198ALIF CAGE 15DEG - 17MM (QTY 25)
00815362023181ALIF CAGE 15DEG - 15MM (QTY 14)
00815362023174ALIF CAGE 15DEG- 13MM (QTY 18)
00815362023167ALIF CAGE 15 degree-11MM (QTY 27)
00815362023150ALIF CAGE 8 DEG - 19MM (QTY 35)
00815362023143ALIF CAGE 8 DEG - 17MM (QTY 31 )
00815362023136ALIF CAGE 8 DEG - 17MM (QTY 28 )
00815362023129ALIF CAGE 8DEG - 15MM (QTY 58 )
00815362023112ALIF CAGE 8 DEG - 15MM (QTY 31 )
00815362023105ALIF CAGE 8 DEG - 15MM (QTY 29 )
00815362023099ALIF CAGE 8 DEG - 13MM (QTY 37)
00815362023082ALIF CAGE 8 DEG - 11MM (QTY 27 )
00815362023075ALIF CAGE 8 DEG- 11MM (QTY 31 )
00815362023068ALIF CAGE 8 DEG - 9MM (QTY 39 )
00815362023051ALIF CAGE 8 deg - 9mm (QTY 27)
00815362023044ALIF CAGE 8 deg - 9mm (QTY 29)
00815362023037ALIF CAGE 8 DEG- 15MM (QTY 223)
00815362023020ALIF CAGE 8 DEG-11MM (QTY 70)

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