FDA.reportPublic FDA data

restor3d Total Talus Replacement

Primary DI
00840097509778
Brand
restor3d Total Talus Replacement
Company
Restor3d, Inc.
Model
1102-04
Device description
Total Talus, No Suture Hole, 105%
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
QNNProsthesis, Total Talus Replacement, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNNProsthesis, Total Talus Replacement, 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
00840097509778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097509778008400975097788400975097780840097509778

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
00840097536705Identity CR KA5253-0001TCR-000- D0012026-09-25
00840097536712Identity CR KA5253-0002TCR-000- D0012026-09-25
00840097536729Identity CR KA 3DP Porous5253-0031TCR-000-D0052026-09-25
00840097536736Identity CR KA 3DP Porous5253-0032TCR-000-D0052026-09-25
00840097536743Identity CR KA 3DP Porous5253-0021TCR-000-SPEC2026-09-25
00840097536750Identity CR KA 3DP Porous5253-0011TCR-000-SPEC2026-09-25
00840097536767Identity CR KA 3DP Porous5253-0022TCR-000-SPEC2026-09-25
00840097536774Identity CR KA 3DP Porous5253-0012TCR-000-SPEC2026-09-25
00840097536781Identity CR KA5253-0901TCR-000-D0012026-09-25
00840097536798Identity CR KA5253-0902TCR-000-D0012026-09-25
00840097536804Identity CR KA 3DP Porous5253-0933TCR-000-D0052026-09-25
00840097536811Identity CR KA 3DP Porous5253-0934TCR-000-D0052026-09-25
00840097533919Veritas Hemiarthroplasty1508-10012026-09-18
00840097533926Veritas Hemiarthroplasty1510-38142026-09-18
00840097533933Veritas Hemiarthroplasty1510-40152026-09-18
00840097533940Veritas Hemiarthroplasty1510-42162026-09-18
00840097533957Veritas Hemiarthroplasty1510-44172026-09-18
00840097533964Veritas Hemiarthroplasty1510-46182026-09-18
00840097533971Veritas Hemiarthroplasty1510-48182026-09-18
00840097533988Veritas Hemiarthroplasty1510-50192026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097509747restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509754restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509761restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509785restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509846restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509853restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509860restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509877restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509884restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509891restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509907restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00889795128119Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128126Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128133Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128768Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128775Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128782Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795137197Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795137203Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795137210Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07