FDA.reportPublic FDA data

ACUITY SURGICAL DEVICES, LLC

Matched from indexed company URL: Acuity Surgical Devices, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108668433010866843ACUITY SURGICAL DEVICES, LLC1N2026-01-018710 N Royal Lane Irving TX US 75063

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810043485043Align - Align ALIF Screw 5.0mm x 25mm T20, STERILE8442284890support@acuitysurgical.com
00810043485050Align - Align Break Off Coverplate Assembly, STERILE(844) 228-4890support@acuitysurgical.com
00810043485210Align - Align ALIF Screw 5.0mm X 20mm T20, STERILE8442284890support@acuitysurgical.com
00810043485227Align - Align ALIF Screw 5.5mm X 20mm T20, STERILE8442284890support@acuitysurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1708071036654876K251735Stabilis SA Cervical Stand-Alone System (Various PNs)OVE2025-07-30
1708071004909737K251335Tera Lumbar Interbody Fusion System (Various PNs)MAX2025-06-02
1708072019939932K243386Ventris Intervertebral Body Fusion DeviceOVD2025-04-22
1708071651673001K241413sagAlign Lumbar Cage System (Various PNs)MAX2024-07-17
1708071242124534K230639Align Cervical Interbody Fusion SystemODP2023-12-01
1708071718443612K222561AlignOVD2022-09-23
1708071802218296K221535Align Lumbar Interbody Fusion SystemMAX2022-07-22
1708071561749189K201671A-Link ZOVD2021-05-04
1708071300390699K150417ASTRA SPINE SYSTEMNKB2015-05-19
1708071930852364K143683APEX-DL Spine SystemNKB2015-05-22
1708071307838935K133827A-LINK ZOVD2014-11-17
1708071020014145K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIFODP2013-09-30
1708071422486217K080537L-VARLOCKMAX2008-06-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX42025-06-02
OVD42025-04-22
ODP22023-12-01
NKB22015-05-22
OVE12025-07-30

PMN#

GUDID#

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