Lapiplasty

GUDID 00853114006112

2.5mm Headless Screw

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00853114006112
NIH Device Record Key169a804e-8f5e-4770-b9c2-8e8fdb34b8a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLapiplasty
Version Model NumberSK20
Company DUNS054808082
Company NameTREACE MEDICAL CONCEPTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853114006112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-13

On-Brand Devices [Lapiplasty]

008531140061122.5mm Headless Screw
008531140060753.5mm Transverse Screw
008531140060683.0mm Interfrag Screw
008531140061984.0 Headless
008531140061744.0 Interfrag

Trademark Results [Lapiplasty]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LAPIPLASTY
LAPIPLASTY
86802324 5115724 Live/Registered
Treace Medical Concepts, Inc.
2015-10-28

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