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 intervertebral body graft containment device
Definition An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
Product CodeOQB
Regulation Number 888.3085
Device Class 2


Premarket Reviews
ManufacturerDecision
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEOLOGY, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 7 7
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 5 5
Expulsion 4 4
Improper or Incorrect Procedure or Method 2 2
Insufficient Information 2 2
Detachment of Device or Device Component 1 1
Malposition of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Failure of Implant 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Perforation of Vessels 1 1
Unspecified Vascular Problem 1 1

-
-