Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bone wedge
Definition Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Product CodePLF
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ADDITIVE DEVICE, INC. (ADI) D/B/A RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 3 3
2021 2 2
2022 4 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Fracture 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Unspecified Infection 2 2
Insufficient Information 2 2
Bacterial Infection 1 1
Failure of Implant 1 1
Swelling 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Implant Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Paragon 28, Inc. II Dec-10-2019
-
-