FDA.reportPublic FDA data

Top Shelf Orthopedics

Primary DI
00850016589187
Brand
Top Shelf Orthopedics
Company
Top Shelf Manufacturing, LLC
Model
510523
Catalog number
510523
Device description
TLSO Brace
Published
2023-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPYOrthosis, Lumbo-Sacral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016589187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016589187008500165891878500165891870850016589187

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-592-0488info@topshelfortho.com

Regulatory Flags#

DUNS number
114134625
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016589194Top Shelf Orthopedics5105245105242023-05-04
00850016589200Top Shelf Orthopedics5105275105272023-05-04
00850016589217Top Shelf Orthopedics5105255105252023-05-04
00850016589224Top Shelf Orthopedics5105265105262023-05-04
00850016589408Top Shelf Orthopedics5082005082002024-03-18
00850016589415Top Shelf Orthopedics5082015082012024-03-18
00850016589422Top Shelf Orthopedics5082025082022024-03-18
00850016589460Top Shelf Orthopedics5082105082102024-03-18
00850016589477Top Shelf Orthopedics5082115082112024-03-18
00850016589484Top Shelf Orthopedics5082125082122024-03-18
00850016589002Top Shelf Orthopedics5300015300012020-12-18
00850016589019Top Shelf Orthopedics5300025300022020-12-18
00850016589026Top Shelf Orthopedics5300035300032020-12-18
00850016589033Top Shelf Orthopedics5300155300152020-12-18
00850016589040Top Shelf Orthopedics5300165300162020-12-18
10850016589009Top Shelf Orthopedics5300015300012020-12-18
10850016589016Top Shelf Orthopedics5300025300022020-12-18
10850016589023Top Shelf Orthopedics5300035300032020-12-18
10850016589030Top Shelf Orthopedics5300155300152020-12-18
10850016589047Top Shelf Orthopedics5300165300162020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854682001967ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001974ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001981ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
06974500613432Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
16974500613439Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
00810113683072Extension Panel - Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-11-25
00810113683492ManaMomma Maternity Back BraceManamed, Inc.IPY2025-10-03
00810113683508ManaMomma Maternity Back Brace, Custom Label Manamed, Inc.IPY2025-10-03
00810113683546Tailback2-50 CureTechManamed, Inc.IPY2025-10-03
00810113682709Tailback2-48Manamed, Inc.IPY2025-09-19
00810113682884Halfback2-50Manamed, Inc.IPY2025-09-19
00810113683058Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-09-19
05391512281229ACTIVDAYINDACO SRLIPY2024-02-09
05391512281236ACTIVDAYINDACO SRLIPY2024-02-09
05391512281250ACTIVDAYINDACO SRLIPY2024-02-09
05391512281267ACTIVDAYINDACO SRLIPY2024-02-09
05391512281755ACTIVDAYINDACO SRLIPY2024-02-09
05391512281762ACTIVDAYINDACO SRLIPY2024-02-09
05391512281779ACTIVDAYINDACO SRLIPY2024-02-09
05391512281786ACTIVDAYINDACO SRLIPY2024-02-09
05391512281793ACTIVDAYINDACO SRLIPY2024-02-09
05391512281809ACTIVDAYINDACO SRLIPY2024-02-09
05391512281816ACTIVDAYINDACO SRLIPY2024-02-09
05391512286026ACTIVDAYINDACO SRLIPY2024-02-09
05391512286033ACTIVDAYINDACO SRLIPY2024-02-09
05391512286057ACTIVDAYINDACO SRLIPY2024-02-09
05391512286064ACTIVDAYINDACO SRLIPY2024-02-09
05391512286095ACTIVDAYINDACO SRLIPY2024-02-09
05391512286101ACTIVDAYINDACO SRLIPY2024-02-09
05391512286118ACTIVDAYINDACO SRLIPY2024-02-09