A Link Z

GUDID 00856037005866

A Link Z Ti Unitary Interbody 32x21x11 12°

ACUITY SURGICAL DEVICES, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00856037005866
NIH Device Record Key6bc45ec8-d504-496a-a680-3c682efabddf
Commercial Distribution StatusIn Commercial Distribution
Brand NameA Link Z
Version Model Number14-32211112
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

Device Dimensions

Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter
Angle12 degree
Height11 Millimeter
Width32 Millimeter
Depth21 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100856037005866 [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

[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


[00856037005866]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-13
Device Publish Date2021-12-03

On-Brand Devices [A Link Z]

00856037005996A Link Z Ti Unitary Interbody 36x26x17 12°
00856037005897A Link Z Ti Unitary Interbody 32x21x15 7°
00856037005880A Link Z Ti Unitary Interbody 32x21x13 12°
00856037005873A Link Z Ti Unitary Interbody 32x21x13 7°
00856037005866A Link Z Ti Unitary Interbody 32x21x11 12°
00856037005859A Link Z Ti Unitary Interbody 32x21x11 7°
00856037005705A Link Z Plate 32x28x17 12°
00856037005699A Link Z Plate 32x28x15 7°
00856037005682A Link Z Plate 32x28x15 12°
00856037005675A Link Z Plate 32x28x13 7°
00856037005668A Link Z Plate 32x28x13 12°
00856037005644A Link Z Plate 32x28x11 12°
00856037005569Cover Plate Assembly
00856037005545A Link Z Screw 5.5mm x 25mm T20
00856037005538A Link Z Screw 5.5mm x 20mm T20
00856037005521A Link Z Screw 5.0mm x 30mm T20
00856037005514A Link Z Screw 5.0mm x 25mm T20
00856037005507A Link Z Screw 5.0mm x 20mm T20
00850812008912A Link Z Ti Unitary FRA Interbody 27x18 12°
00850812008905A Link Z Ti Unitary FRA Interbody 27x18 7°
00850812008899A Link Z Ti Unitary FRA Interbody 27x16 12°
00850812008882A Link Z Ti Unitary FRA Interbody 27x16 7°
00850812008875A Link Z Ti Unitary FRA Interbody 27x14 12°
00850812008868A Link Z Ti Unitary FRA Interbody 27x14 7°
00850812008851A Link Z Ti Unitary FRA Interbody 27x12 12°
00850812008844A Link Z Ti Unitary FRA Interbody 27x12 7°
00850812008837A Link Z Ti Unitary FRA Interbody 27x10 12°
00850812008820A Link Z Ti Unitary FRA Interbody 27x10 7°
00850812008547A Link Z Ti Unitary FRA Interbody 27x17 12°
00850812008516FRA Cover Plate Assembly
00850812008509A Link Z Ti Unitary FRA Interbody 27x17 7°
00850812008493A Link Z Ti Unitary FRA Interbody 27x15 12°
00850812008486A Link Z Ti Unitary FRA Interbody 27x15 7°
00850812008479A Link Z Ti Unitary FRA Interbody 27x13 12°
00850812008462A Link Z Ti Unitary FRA Interbody 27x13 7°
00850812008455A Link Z Ti Unitary FRA Interbody 27x11 12°
00850812008448A Link Z Ti Unitary FRA Interbody 27x11 7°
00850812008431A Link Z Ti Unitary FRA Interbody 27x9 12°
00850812008424A Link Z Ti Unitary FRA Interbody 27x9 7°
00850812008219A Link Z Ti Unitary Interbody 32x21x13 20°
00850812008202A Link Z Ti Unitary Interbody 32x21x13 16°
00850812008127A Link Z Ti Unitary Interbody 36x26x17 20°
00850812008110A Link Z Ti Unitary Interbody 36x26x17 16°
00810043480994A Link Z Ti Unitary Open Interbody 32x24x19 12°
00810043480970A Link Z Ti Unitary Open Interbody 32x24x18 12°
00810043480963A Link Z Ti Unitary Open Interbody 32x24x18 7°
00810043480581Far AL Compact Implant Retainer
00810043480574Far AL Inserter
00810043480567Large Angle Far AL Oblique Implant Retainer
00810043480550Small Angle Far AL Oblique Implant Retainer

Trademark Results [A Link Z]

Mark Image

Registration | Serial
Company
Trademark
Application Date
A LINK Z
A LINK Z
87545232 5416820 Live/Registered
Acuity Surgical Devices, LLC
2017-07-27

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