FDA.reportPublic FDA data

Lapiplasty SpeedPlate

Primary DI
00810111222600
Brand
Lapiplasty SpeedPlate
Company
Treace Medical Concepts, Inc.
Model
02-00183
Device description
Inserter Rod
Published
2024-06-03
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
JDRStaple, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111222600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111222600008101112226008101112226000810111222600

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111227346Scalpel 02-003872026-05-19
00810111227223SpeedMTP SelectSK692026-05-13
00810111227247SpeedMTP SelectSD342026-05-13
00810111227254SpeedMTP SelectSD332026-05-13
00810111225663X-ray App12-000012026-05-01
00810111226769ReamerSN502026-05-01
00810111226776ReamerSN512026-05-01
00810111226783ReamerSN522026-05-01
00810111227261K-Wire02-005202026-04-27
00810111224987Screwdriver02-004402026-04-15
00810111225007Screwdriver02-004422026-04-15
00810111225021Screwdriver02-004442026-04-15
00810111225069Screwdriver02-004482026-04-15
00810111225458Instrument Tray02-004822026-04-15
00810111225670Screwdriver02-005062026-04-15
00810111225687Percuplasty SuperBite Compression ScrewSC701302026-04-15
00810111225694Percuplasty SuperBite Compression ScrewSC701252026-04-15
00810111225700Percuplasty SuperBite Compression ScrewSC701202026-04-15
00810111225717Percuplasty SuperBite Compression ScrewSC701152026-04-15
00810111225724Percuplasty SuperBite Compression ScrewSC701102026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.JDR2026-03-30
00810111224833TMC Nanoplasty SystemTreace Medical Concepts, Inc.JDR2025-10-10
00811714036458Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
00811714036465Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042640Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042671Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042688Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00811714035352Thunderbolt PlateRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
07630971238039MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238046MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238053MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238060MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238077MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238084MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238091MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238107MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238114MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238121MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
00815432025138MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2018-08-06