Align

GUDID 00810043484633

Align PEEK Unitary Cage 32x21x15 7°

ACUITY SURGICAL DEVICES, LLC

Metallic spinal interbody fusion cage
Primary Device ID00810043484633
NIH Device Record Key28f06409-62b3-472f-a9ad-f13862ff361d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlign
Version Model Number12-32211507
Company DUNS025855111
Company NameACUITY SURGICAL DEVICES, LLC
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

Customer Support Contacts

Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com
Phone8442284890
Emailsupport@acuitysurgical.com

Device Dimensions

Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree
Length32 Millimeter
Width21 Millimeter
Height15 Millimeter
Angle7 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100810043484633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

[00810043484633]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-13
Device Publish Date2024-02-05

On-Brand Devices [Align ]

00810043486880Align Ti Lateral Interbody 22x60x11 7°
00810043486866Align Ti Lateral Interbody 22x60x10 12°
00810043486842Align Ti Lateral Interbody 22x60x10 7°
00810043486828Align Ti Lateral Interbody 22x60x9 12°
00810043486804Align Ti Lateral Interbody 22x60x9 7°
00810043486781Align Ti Lateral Interbody 22x60x8 12°
00810043486767Align Ti Lateral Interbody 22x60x8 7°
00810043486743Align Ti Lateral Interbody 22x60x7 7°
00810043486705Align Ti Lateral Interbody 22x55x17 7°
00810043486682Align Ti Lateral Interbody 22x55x15 12°
00810043486668Align Ti Lateral Interbody 22x55x15 7°
00810043486644Align Ti Lateral Interbody 22x55x13 12°
00810043486620Align Ti Lateral Interbody 22x55x13 7°
00810043486606Align Ti Lateral Interbody 22x55x11 12°
00810043486583Align Ti Lateral Interbody 22x55x11 7°
00810043486569Align Ti Lateral Interbody 22x55x10 12°
00810043486521Align Ti Lateral Interbody 22x55x9 12°
00810043486507Align Ti Lateral Interbody 22x55x9 7°
00810043486484Align Ti Lateral Interbody 22x55x8 12°
00810043486460Align Ti Lateral Interbody 22x55x8 7°
00810043486446Align Ti Lateral Interbody 22x55x7 7°
00810043486422Align Ti Lateral Interbody 22x50x17 12°
00810043486408Align Ti Lateral Interbody 22x50x17 7°
00810043486385Align Ti Lateral Interbody 22x50x15 12°
00810043486361Align Ti Lateral Interbody 22x50x15 7°
00810043486347Align Ti Lateral Interbody 22x50x13 12°
00810043486323Align Ti Lateral Interbody 22x50x13 7°
00810043486309Align Ti Lateral Interbody 22x50x11 12°
00810043486286Align Ti Lateral Interbody 22x50x11 7°
00810043486262Align Ti Lateral Interbody 22x50x10 12°
00810043486248Align Ti Lateral Interbody 22x50x10 7°
00810043486224Align Ti Lateral Interbody 22x50x9 12°
00810043486200Align Ti Lateral Interbody 22x50x9 7°
00810043486187Align Ti Lateral Interbody 22x50x8 12°
00810043486163Align Ti Lateral Interbody 22x50x8 7°
00810043486149Align Ti Lateral Interbody 22x50x7 7°
00810043486125Align Ti Lateral Interbody 22x45x17 12°
00810043486101Align Ti Lateral Interbody 22x45x17 7°
00810043486088Align Ti Lateral Interbody 22x45x15 12°
00810043486064Align Ti Lateral Interbody 22x45x15 7°
00810043486040Align Ti Lateral Interbody 22x45x13 12°
00810043486026Align Ti Lateral Interbody 22x45x13 7°
00810043486002Align Ti Lateral Interbody 22x45x11 12°
00810043485982Align Ti Lateral Interbody 22x45x11 7°
00810043485968Align Ti Lateral Interbody 22x45x10 12°
00810043485944Align Ti Lateral Interbody 22x45x10 7°
00810043485920Align Ti Lateral Interbody 22x45x9 12°
00810043485906Align Ti Lateral Interbody 22x45x9 7°
00810043485883Align Ti Lateral Interbody 22x45x8 12°
00810043487238Align Ti Lateral Interbody 18x55x14 7°

Trademark Results [Align]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALIGN
ALIGN
98871868 not registered Live/Pending
Xsolis, Inc.
2024-11-25
ALIGN
ALIGN
98718570 not registered Live/Pending
ALIGN PRODUCTION SYSTEMS, LLC
2024-08-27
ALIGN
ALIGN
98525294 not registered Live/Pending
Portals Paper Limited
2024-04-29
ALIGN
ALIGN
98474424 not registered Live/Pending
GILMAN BROTHERS COMPANY, THE
2024-03-29
ALIGN
ALIGN
98449553 not registered Live/Pending
BenDavid, Dina
2024-03-14
ALIGN
ALIGN
98376430 not registered Live/Pending
Civco Medical Instruments Co., Inc.
2024-01-25
ALIGN
ALIGN
97826844 not registered Live/Pending
Tidal Vision Products, Inc.
2023-03-07
ALIGN
ALIGN
97826830 not registered Live/Pending
Tidal Vision Products, Inc.
2023-03-07
ALIGN
ALIGN
97796036 not registered Live/Pending
BenDavid, Dina
2023-02-15
ALIGN
ALIGN
97730584 not registered Live/Pending
Self-Help Technologies
2022-12-23
ALIGN
ALIGN
97616631 not registered Live/Pending
IntelliGenesis, LLC
2022-10-03
ALIGN
ALIGN
97469934 not registered Live/Pending
American Sentinel University, Inc.
2022-06-22
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.