FDA.reportPublic FDA data

restor3d Total Talus Replacement

Primary DI
00840097509815
Brand
restor3d Total Talus Replacement
Company
Restor3d, Inc.
Model
1102-13
Device description
Total Talus, With Suture Hole, 100%
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
00840097509815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097509815008400975098158400975098150840097509815

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
00840097535678Veritas rTSA3500-142U12026-06-03
00840097535692Veritas rTSA3500-142C12026-06-03
00840097535715Veritas rTSA3500-142U32026-06-03
00840097535739Veritas rTSA3500-142C32026-06-03
00840097535753Veritas rTSA3500-342U12026-06-03
00840097535777Veritas rTSA3500-342C12026-06-03
00840097535791Veritas rTSA3500-342U32026-06-03
00840097535814Veritas rTSA3500-342C32026-06-03
00840097535838Veritas rTSA3500-542U12026-06-03
00840097535852Veritas rTSA3500-542C12026-06-03
00840097535876Veritas rTSA3500-542U32026-06-03
00840097535890Veritas rTSA3500-542C32026-06-03
00840097534978Veritas rTSA1501-42012026-06-02
00840097534985Veritas rTSA1501-42042026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097509792restor3d Total Talus ReplacementRestor3d, Inc.QYQ2024-03-15
00840097509808restor3d 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