Tailback2-56 TB056-2

GUDID 00810113682716

The Tailback2-56 is a universal thoracic-lumbar-sacral orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Padded shoulder straps make applying the brace quick and easy. The thoracic extension telescopes to various heights to insure proper fits for all anatomy. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system

Manamed, Inc.

Lumbar spine orthosis
Primary Device ID00810113682716
NIH Device Record Keyc9a53152-dce1-4ed5-8a17-829e863fa347
Commercial Distribution StatusIn Commercial Distribution
Brand NameTailback2-56
Version Model NumberTB056-2
Catalog NumberTB056-2
Company DUNS084042331
Company NameManamed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113682716 [Primary]

FDA Product Code

IPTOrthosis, Thoracic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-29
Device Publish Date2025-09-19

Devices Manufactured by Manamed, Inc.

00810113682891 - ManaEZ Ankle 06 Extra Small2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr
00810113682907 - ManaEZ Ankle 06 Small2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr
00810113682914 - ManaEZ Ankle 06 Medium2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr
00810113682921 - ManaEZ Ankle 06 Large2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr
00810113682938 - ManaEZ Ankle 06 Extra Large2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr
00810113682945 - ManaEZ Ankle 06 Extra Extra Large2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr
00810113683126 - ManaEZ Night Splint, Plantar Fasciitis, Small2025-10-06 Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight A
00810113683133 - ManaEZ Night Splint, Plantar Fasciitis, Medium2025-10-06 Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight A

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.