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 fixation cerclage, sublaminar
Definition Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Product CodeOWI
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S. A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 8 8
2021 5 5
2022 6 6
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Material Rupture 6 6
Device Damaged by Another Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Material Split, Cut or Torn 2 2
Expulsion 2 2
Patient-Device Incompatibility 2 2
Material Deformation 2 2
Mechanical Problem 1 1
Output above Specifications 1 1
Positioning Failure 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1
Fracture 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Bone Fracture(s) 5 5
Pain 5 5
No Code Available 3 3
Failure of Implant 3 3
Unspecified Infection 1 1
Patient Problem/Medical Problem 1 1
Inflammation 1 1
Spinal Column Injury 1 1
Fever 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medicrea International II Nov-17-2020
-
-