Brickyard ALIF

GUDID 00843210183503

38mm x 27mm, 20°, 17mm Ti Spacer

Altus Spine, LLC

Spinal implant trial
Primary Device ID00843210183503
NIH Device Record Keyeaabffac-a7db-4500-b3c0-5770f098e64e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrickyard ALIF
Version Model NumberFA38272017T
Company DUNS078331322
Company NameAltus Spine, LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210183503 [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

[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


[00843210183503]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-09
Device Publish Date2024-08-30

On-Brand Devices [Brickyard ALIF]

0084321017794642mm x 30mm, 20°, 17mm Trial
0084321018552132mm x 24mm, 8°, 9mm Ti Spacer
0084321018550732mm x 24mm, 8°, 11mm PEEK Spacer
0084321018548432mm x 24mm, 8°, 11mm Ti Spacer
0084321018546032mm x 24mm, 8°, 13mm PEEK Spacer
0084321018544632mm x 24mm, 8°, 13mm Ti Spacer
0084321018542232mm x 24mm, 8°, 15mm PEEK Spacer
0084321018541532mm x 24mm, 8°, 15mm Ti Spacer
0084321018539232mm x 24mm, 8°, 17mm PEEK Spacer
0084321018538532mm x 24mm, 8°, 17mm Ti Spacer
0084321018536132mm x 24mm, 8°, 19mm PEEK Spacer
0084321018535432mm x 24mm, 8°, 19mm Ti Spacer
0084321018534732mm x 24mm, 12°, 9mm PEEK Spacer
0084321018533032mm x 24mm, 12°, 9mm Ti Spacer
0084321018531632mm x 24mm, 12°, 11mm PEEK Spacer
0084321018530932mm x 24mm, 12°, 11mm Ti Spacer
0084321018529332mm x 24mm, 12°, 13mm PEEK Spacer
0084321018527932mm x 24mm, 12°, 13mm Ti Spacer
0084321018526232mm x 24mm, 12°, 15mm PEEK Spacer
0084321018524832mm x 24mm, 12°, 15mm Ti Spacer
0084321018522432mm x 24mm, 12°, 17mm PEEK Spacer
0084321018520032mm x 24mm, 12°, 17mm Ti Spacer
0084321018519432mm x 24mm, 12°, 19mm PEEK Spacer
0084321018517032mm x 24mm, 12°, 19mm Ti Spacer
0084321018511832mm x 24mm, 16°, 11mm PEEK Spacer
0084321018510132mm x 24mm, 16°, 11mm Ti Spacer
0084321018508832mm x 24mm, 16°, 13mm PEEK Spacer
0084321018507132mm x 24mm, 16°, 13mm Ti Spacer
0084321018505732mm x 24mm, 16°, 15mm PEEK Spacer
0084321018503332mm x 24mm, 16°, 15mm Ti Spacer
0084321018502632mm x 24mm, 16°, 17mm PEEK Spacer
0084321018500232mm x 24mm, 16°, 17mm Ti Spacer
0084321018498232mm x 24mm, 16°, 19mm PEEK Spacer
0084321018497532mm x 24mm, 16°, 19mm Ti Spacer
0084321018496832mm x 24mm, 20°, 13mm PEEK Spacer
0084321018495132mm x 24mm, 20°, 13mm Ti Spacer
0084321018493732mm x 24mm, 20°, 15mm PEEK Spacer
0084321018492032mm x 24mm, 20°, 15mm Ti Spacer
0084321018491332mm x 24mm, 20°, 17mm PEEK Spacer
0084321018490632mm x 24mm, 20°, 17mm Ti Spacer
0084321018488332mm x 24mm, 20°, 19mm PEEK Spacer
0084321018486932mm x 24mm, 20°, 19mm Ti Spacer
0084321018485232mm x 24mm, 25°, 15mm PEEK Spacer
0084321018483832mm x 24mm, 25°, 15mm Ti Spacer
0084321018482132mm x 24mm, 25°, 17mm PEEK Spacer
0084321018481432mm x 24mm, 25°, 17mm Ti Spacer
0084321018479132mm x 24mm, 25°, 19mm PEEK Spacer
0084321018478432mm x 24mm, 25°, 19mm Ti Spacer
0084321018476034mm x 26mm, 8°, 9mm PEEK Spacer
0084321018475334mm x 26mm, 8°, 9mm Ti Spacer

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