restor3d Total Talus Replacement

Primary DI
00840097509792
Brand
restor3d Total Talus Replacement
Company
Restor3d, Inc.
Model
1102-11
Device description
Total Talus, With Suture Hole, 90%
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, MetalUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H230003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H230003000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097509792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097509792008400975097928400975097920840097509792

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made hand/foot bone prosthesisAn implantable device designed and created for a specific patient to replace the whole or part of a bone in the hand or foot, including the wrist or ankle (e.g., carpal, metacarpal, tarsal or metatarsal bones), typically to treat avascular necrosis or other osteolytic conditions. It is made of metal [e.g., titanium (Ti) alloy]. Devices intended to assist implantation (e.g., trial prosthesis, surgical guide) may be included with the prosthesis.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097513218Veritas rTSA1500-10152026-05-14
00840097513225Veritas rTSA1500-10302026-05-14
00840097513232Veritas rTSA1500-10352026-05-14
00840097513249Veritas rTSA1500-10452026-05-14
00840097532356Veritas rTSA Instrumentation6500-20472026-05-14
00840097532394Veritas rTSA Instrumentation5500-40012026-05-14
00840097532400Veritas rTSA Instrumentation5500-41112026-05-14
00840097532417Veritas rTSA Instrumentation5500-43012026-05-14
00840097532424Veritas rTSA Instrumentation5500-44012026-05-14
00840097533780Total Knee Instrumentation5201-10042026-05-14
00840097533797Total Knee Instrumentation5201-10052026-05-14
00840097533803Total Knee Instrumentation5201-10062026-05-14
00840097533810Veritas rTSA Instrumentation5500-42012026-05-14
00840097534169Ossera™ AFX Instrumentation5740-98112026-05-14
00840097534176Ossera™ AFX Instrumentation5740-98122026-05-14
00840097534299Veritas rTSA1501-3202-N2026-05-14
00840097535968Veritas rTSA Instrumentation5500-45012026-05-14
00840097535975Veritas rTSA Instrumentation5500-H42U12026-05-14
00840097535999Veritas rTSA Instrumentation5500-H42U32026-05-14
00840097536385Veritas rTSA Instrumentation4520-10042026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097509808restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509815restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509822restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509839restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509846restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509853restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509860restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509877restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509884restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509891restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509907restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15