Lapiplasty Select

GUDID 00853114006273

Anatomic Biplanar Implants

TREACE MEDICAL CONCEPTS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID00853114006273
NIH Device Record Key33504f27-0103-435b-969b-3be6548ae643
Commercial Distribution StatusIn Commercial Distribution
Brand NameLapiplasty Select
Version Model NumberSK34
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
GS100853114006273 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by TREACE MEDICAL CONCEPTS, INC.

00853114006273 - Lapiplasty Select2021-07-22Anatomic Biplanar Implants
00853114006273 - Lapiplasty Select2021-07-22 Anatomic Biplanar Implants
00853114006211 - Lapiplasty Mini Incision System2021-01-25 Anatomic Biplanar Implants
00853114006235 - FASTPITCH 2.7MM HIGH PITCH LOCKING SCREW2021-01-25 Locking Screws
00853114006228 - PLANTARPOWER PLATE2020-07-28 Anatomic Tension Side Plate
00853114006198 - Lapiplasty2020-04-07 4.0 Headless
00853114006204 - Lapiplasty Lesser TMT Fixation Pack2020-04-07 Anatomic Fixation
00853114006174 - Lapiplasty2019-07-30 4.0 Interfrag
00853114006143 - Snap-Off Screw System2019-07-02 2.0mm Snap-Off Screw System

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.