FDA.reportPublic FDA data

Plantar Python 2 Left

Primary DI
00853114006082
Brand
Plantar Python 2 Left
Company
Treace Medical Concepts, Inc.
Model
SD14
Device description
Anatomic Tension Side Plate
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853114006082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853114006082008531140060828531140060820853114006082

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054808082
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111228527Drill Guide02-006302026-09-21
00810111224680TMC PSI Cut Guide SystemPSI-02-003862025-05-22
00810111224697TMC PSI Cut Guide SystemPSI-02-003852025-05-22
00810111223447TMC PSI Cut Guide SystemNK232024-11-14
00810111223454TMC PSI Cut Guide SystemNK242024-11-14
00810111223478TMC PSI Cut Guide SystemNK262024-11-14
00810111223553TMC PSI Cut Guide SystemPSI-02-002332024-11-15
00810111223560TMC PSI Cut Guide SystemPSI-02-002322024-11-15
00810111223577TMC PSI Cut Guide SystemPSI-02-002312024-11-15
00810111223584TMC PSI Cut Guide SystemPSI-02-002302024-11-15
00810111223621TMC PSI Cut Guide SystemNK272024-11-14
00810111222723TMC PSI Cut Guide SystemPSI-02-001632024-03-11
00810111222730TMC PSI Cut Guide SystemPSI-02-001622024-03-11
00810111222259TMC PSI Cut Guide SystemNK152023-11-17
00810111222266TMC PSI Cut Guide SystemPSI-01-2029-0212023-11-17
00810111222273TMC PSI Cut Guide SystemPSI-01-2229-0212023-11-17
00810111222280TMC PSI Cut Guide SystemPSI-01-2129-0212023-11-17
00810111222297TMC PSI Cut Guide SystemPSI-01-2329-0212023-11-17
00810111222327TMC PSI Cut Guide SystemPSI-06-1032-0142023-11-17
00810111222358TMC PSI Cut Guide SystemPSI-02-1610-0062023-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
10886982350756VOLTSynthes GmbHHRS2026-09-25
10886982350763VOLTSynthes GmbHHRS2026-09-25
10886982350770VOLTSynthes GmbHHRS2026-09-25
10886982350787VOLTSynthes GmbHHRS2026-09-25
10886982350794VOLTSynthes GmbHHRS2026-09-25
10886982350800VOLTSynthes GmbHHRS2026-09-25
10886982350817VOLTSynthes GmbHHRS2026-09-25
10886982350824VOLTSynthes GmbHHRS2026-09-25
10886982350831VOLTSynthes GmbHHRS2026-09-25
10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
10886982350862VOLTSynthes GmbHHRS2026-09-25
10886982350879VOLTSynthes GmbHHRS2026-09-25