FDA.reportPublic FDA data

Patient Specific Talus Spacer

Primary DI
00889795128775
Brand
Patient Specific Talus Spacer
Company
Paragon 28, Inc.
Model
AOPSTT-XXXXN
Catalog number
AOPSTT-XXXXN
Device description
Patient Specific Talus Trial, Nominal, Nylon
Published
2024-03-07
Public version status
Update
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
QNNProsthesis, Total Talus Replacement, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNNProsthesis, Total Talus Replacement, MetalUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H200001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H200001000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795128775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795128775008897951287758897951287750889795128775

GMDN Terms#

Term, Definition table
TermDefinition
Coated ankle talus prosthesisA sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795118011Monkey Rings™ External Fixation SystemP45-511-0001P45-511-00012026-05-06
00889795152114Monkey Rings™ External Fixation SystemP45-113-0120P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemP45-113-0140P45-113-01402026-05-06
00889795152138Monkey Rings™ External Fixation SystemP45-113-0160P45-113-01602026-05-06
00889795152145Monkey Rings™ External Fixation SystemP45-113-0180P45-113-01802026-05-06
00889795152152Monkey Rings™ External Fixation SystemP45-113-0200P45-113-02002026-05-06
00889795152169Monkey Rings™ External Fixation SystemP45-113-0220P45-113-02202026-05-06
00889795152176Monkey Rings™ External Fixation SystemP45-191-4650P45-191-46502026-05-06
00889795152183Monkey Rings™ External Fixation SystemP45-191-5055P45-191-50552026-05-06
00889795152190Monkey Rings™ External Fixation SystemP45-191-5070P45-191-50702026-05-06
00889795152206Monkey Rings™ External Fixation SystemP45-191-6055P45-191-60552026-05-06
00889795152213Monkey Rings™ External Fixation SystemP45-191-6070P45-191-60702026-05-06
00889795152244Monkey Rings™ External Fixation SystemP45-196-4650P45-196-46502026-05-06
00889795152251Monkey Rings™ External Fixation SystemP45-196-5055P45-196-50552026-05-06
00889795152268Monkey Rings™ External Fixation SystemP45-196-5070P45-196-50702026-05-06
00889795152275Monkey Rings™ External Fixation SystemP45-196-6055P45-196-60552026-05-06
00889795152282Monkey Rings™ External Fixation SystemP45-196-6070P45-196-60702026-05-06
00889795152299Monkey Rings™ External Fixation SystemP45-197-2333P45-197-23332026-05-06
00889795152367Monkey Rings™ External Fixation SystemP45-334-1000P45-334-10002026-05-06
00889795152374Monkey Rings™ External Fixation SystemP45-334-1001P45-334-10012026-05-06

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
00840097509778restor3d 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
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